Triathlon Knee System Anterior Referencing … Triathlon Anterior...2 Triathlon Knee System Anterior...

TriathlonKnee System

Anterior ReferencingSurgical Protocol

Triathlon Knee SystemAnterior Referencing Surgical Protocol

Table of Contents

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

Assembly Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Tibial Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Rotational Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Varus-Valgus Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Flexion-Extension Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Establishing the Tibial Resection Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Final Tibial Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Femoral Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Rotational Alignment - Option 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22




Anterior Skim Cut Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Distal Femoral Resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Femoral Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Alternative A/P Sizing Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

PS Box Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

Gap and Ligament Balancing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

Femoral Trial Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

Tibial Component Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Tibial Keel Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Trial Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Patella Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

Patella Trial Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Final Preparation and Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Tibia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Femur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Symmetric or Asymmetric Patella . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

CR or PS Tibial Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

Rehabilitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Catalog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48

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AcknowledgmentsStryker Orthopaedics wishes to thank Dr. Steven F. Harwin, principal contributor,for his extensive help in the writing of the A/R Surgical Protocol.

Stryker Orthopaedics also wishes to thank the following orthopaedic surgeons for their expertise and guidance in the development of the Triathlon A/Rinstrumentation and for editing and reviewing the A/R Surgical Protocol.

Triathlon A/R Instrumentation Surgeon Panel

Steven F. Harwin, M.D., F.A.C.S., ChairPeter M. Bonutti, M.D.Stephen Incavo, M.D.Mario Manili, M.D.Marc Rosen, M.D.Scott Schoifet, M.D.Kipling Sharpe, M.D.Stephen Zelicof, M.D.

AssemblyInstructions

The Triathlon Knee System Instrumentation features mechanisms that providesurgeons and OR Staff a more simplified and efficient surgical experience. Assemblyinstructions are included in the first section of this surgical technique to assist withinstruments that may be pre-assembled on the back table, as well as otherinstruments that need to be assembled. All of the actuating mechanisms that allowinstruments to be adjusted and/or assembled have been color-coded. Those thatcorrespond to femoral preparation are black, those for tibial preparation are bronzeand those for patella preparation are gold.

Black Bronze Gold

Note: Any instrument that has been dropped should be returned to Stryker forevaluation prior to further use.

Assembly 1A

Assembly 1B

Assembly 1C

Tibial Alignment Ankle Clamp EM, TibialAlignment Distal Assembly EM, MIS ProximalRod EM, Tibial Stylus, MIS Tibial ResectionGuide, and Tibial Adjustment Housing Assembly:

> Press the bronze button 1 and advance the DistalAssembly arm forward approximately halfway.

> Press the bronze button 2 on the Distal Assembly;put the arm into the grooves on the Ankle Clamp.Ensure that the side of the Ankle Clamp reading“proximal” is visible from above.

> Press the bronze wheel on the inferior portion of theTibial Adjustment Housing with your thumb andinsert the Proximal Rod from the superior side.

> With the bronze wheel depressed, slide the TibialAdjustment Housing up to approximately 5cm fromthe arm of the Proximal Rod.

> Release the bronze wheel to engage the teeth of theProximal Rod and lock the Adjustment Housing inplace.

Note: The Tibial Adjustment Housing is available in 0 degree slope (posterior stabilized) and 3 degree slope(cruciate retaining).

> Ensure that the bronze slide lock on the superiorportion of the Distal Assembly is in the unlockedposition prior to insertion of the Proximal Rod andTibial Adjustment Housing assembly.

> Insert the Proximal Rod and Tibial AdjustmentHousing assembly into the hole on the superiorportion of the Distal Assembly. Note: Ensure theProximal Rod arm extends in the same direction asthe assembled Ankle Clamp.


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Assembly 1D

Assembly 1E

Assembly 1F

> Squeeze the bronze tabs on the Tibial AdjustmentHousing and assemble the MIS Captured,MIS Uncaptured, or Standard Uncaptured Tibial Resection Guide with the resection surfacefacing up.

> Release the bronze tabs and ensure that the Tibial Resection Guide is locked in place.

> Squeeze the bronze swing trigger on the Tibial Stylusand insert the post into either the medial or lateralhole located on the resection plane of the TibialResection Guide.

> Release the bronze swing trigger to lock the TibialStylus in place.

> The MIS Proximal Rod has a retractable tibialplateau referencing arm. Ensure that the armposition is fully extended; to extend or retract thefixation arm, depress the bronze button on theleft side of the MIS Proximal Rod and slide thefixation arm.

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Assembly 4

3 Degree Posterior Condylar Reference Guide Assembly:

> Slide the 3 Degree Posterior Condylar ReferenceGuide hooks over the set screws.

Assembly 2

Assembly 3

MIS Femoral Alignment Guide and AnteriorSkim Cut Guide Assembly:

> Orient the MIS Femoral Alignment Guide such thatthe TKR being performed “Right” or “Left” facesanteriorly.

> Insert the Anterior Skim Cut Guide into the twoanterior holes on the MIS Femoral Alignment Guidewith the label “THIS SIDE TOWARDS BONE”appropriately positioned.

1/8'' Hex Driver Assembly:

> Snap the 1/8'' Hex Drive into the Slip TorqueHandle


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Assembly 5A

Assembly 5B

MIS Distal Resection Guide Assembly:

> Select the 8mm or 10mm MIS Distal ResectionGuide

> Assemble the Triathlon Modular Handle to theselected distal resection guide by depressing theblack button on the modular handle and insertingthe tip into the medial or lateral hole on the top ofthe distal resection guide.

> Release the black button and rotate the handle 20 degrees away from center to lock.

> Align the oval hole on the Distal Resection Guidewith the tab on the superior face of the AnteriorSkim Cut Guide.

> Slide the Distal Resection Guide towards the SkimCut Guide to insert the tab into the oval hole.

> These guides are magnetized to facilitate correctassembly. This will be done intra-operatively byresting the Distal Resection Guide on the cut surfaceof the anterior femur and then sliding it into place,connecting it to the Anterior Skim Cut Guide.

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4:1 Block Assembly:

TopView

SideView

> Align the Impactor / Extractor about 5mmto the left or right of the AR 4:1 Blockcentral spine.

> Maintaining forward pressure, release thetrigger and slide the 4:1 Impactor/Extractorhandle to the center. A click indicates asuccessful lock.

Step 1: Align and Insert Step 2: Slide and Lock

> To disengage the 4:1 Impactor/Extractor from the Cutting Block,reverse the above steps.

Assembly 6

> Final Assembly

Assembly 7A

Assembly 7B

Assembly 8

MIS Femoral Trial Extractor and Femoral Trial,PS Box Guide, or AR 4-in-1 Cutting Guide:

Orient the non-rubber coated side of the MIS FemoralTrial Extractor towards the patella.

> Without squeezing the handle, insert the postsfirmly into the lugholes of the femoral trial,PS box guide.

> Squeeze the handle of the MIS Femoral TrialExtractor to hold securely. Releasing the handle willrelease the coupled instrument.

> Final assembly with Femoral Trial.

> Assembly with PS Box Guide is performed similarly(inset).

Skim Cut Stylus Assembly:

> Squeeze the smaller black swing trigger on the bodyof the Femoral Stylus.

> Insert the Femoral Stylus into the hole on the topsurface of the Anterior Skim Cut Guide.

Note: As a safety measure, the stylus will fully engageonly when the skim cut guide is properly oriented andthe tip of the stylus is facing towards bone.

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Assembly 9A

Assembly 9B

Assembly 9C

Tibial Template, Alignment Handle and PS or CR Tibial Insert Trial Assembly:

> Posterior hole and Channel of Universal TibialTemplate.

> Press the back of the bronze lever on the AlignmentHandle to disengage the pawl. With the handle at aslight angle to the top surface of the template, insertthe spring-loaded tip of the Alignment Handle intothe central posterior hole of the Universal TibialTemplate.

> Compress the spring-loaded tip by pushing itforward and lower the Alignment Handle into thechannel on the anterior portion of the UniversalTibial Template. Release the spring tension andallow the Alignment Handle to engage the UniversalTibial Template channel tabs.

> The Tibial Insert Trial can be assembled with theTibial Alignment Handle in place. Insert theposterior catches into the tray’s posterior undercutsat a slight angle. Lower the trial until it seats firmly.

Note: The insert trial does not lock into place.


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Assembly 10A

Assembly 10B

Assembly 10C

> Rotate the Keel Punch Guide down to sit flat on theUniversal Tibial Template and push forward on thehandle of the Keel Punch Guide to lock it to theUniversal Tibial Template. Ensure that the KeelPunch Guide is seated flat on the Universal TibialTemplate prior to locking.

Universal Tibial Template and Keel Punch Guide Assembly:

> Ensure that the handle of the Keel Punch Guide isunlocked – pull back on the handle to unlock.

> Assemble the Keel Punch Guide to the UniversalTibial Template by inserting the Keel Punch Guide,at a slight angle to the Universal Tibial Template,into the two locating slots towards the posteriorportion of the Universal Tibial Template.

> Final Assembly

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Assembly 11A

Assembly 11B

Assembly 12

Patella Clamp, Patella Stylus and Patella ClampJaws Assembly (this may also be used to assemblethe Patella Clamp Base, Patella Drill Templateand Patella Cement Cap to the Patella Clamp):

> Snap the Patella Clamp Jaws into the holes on thePatella Clamp.

> Squeeze the gold tab on the Patella Stylus and insertthe post into the hole on either jaw. Use the holeson the top surface of the jaws if using the boneremoving method or on the bottom surface if usingthe bone remaining method.

> The top surface has circular holes, which allow thestylus to rotate, and the bottom surface has hexshaped holes fixing the stylus in the center of thepatella.

> Release the gold tab to lock the Patella Stylus in place.

MIS Femoral Flexion Impactor:

> Connect the MIS Femoral Flexion Impactor to theImpaction Handle.

> The MIS Femoral Flexion Impactor is placed in theintertrochlear groove of the femoral implant andused to begin impaction of the implant onto thedistal femur.


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Assembly 13

Assembly 14

> Insert the tip of the 1/8'' Hex Drive into theModular Femoral Distal Fixation Peg and turn theSlip Torque Handle to tighten.

Patella and Tibia Protector Plate (optional):

> The intended use of the patella and tibia protectorplates are to protect trabecular bone on the cutsurface of the patella and tibia after osteotomies aremade.

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Assembly 15A

Assembly 15B

Assembly 15C

Femoral Impactor/Extractor, Impaction Handle,and Femoral Trial or Femoral ComponentAssembly:

> Press the handle button on the Impaction Handleand insert the the Femoral Impactor/Extractor intothe Impaction Handle.

> Ensure the hexagon on the Femoral Impactor/Extractor is fully seated in the Impaction Handle.When fully seated, there will be an audible snap.

> Turn the Impaction Handle counterclockwise untilthere is enough space (approximately 10mm)between the black impaction surface and the ends ofthe jaws to insert the Femoral Trial or Femoralcomponent.

> Pull back on the mechanism to open the jaws.Engage the jaws into the impaction slots on theFemoral Trial or Femoral Component.

> Turn the Impaction Handle clockwise to tighten,ensuring the impaction surface locks against thedistal condyles of the Femoral Trial or FemoralComponent.


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SurgicalProcedure

Exposure

> Total knee arthroplasty should be performed using the least invasiveapproach with which the surgeon is comfortable. The Triathlon Knee Systeminstrumentation is suitable for use with any minimally or less invasiveapproach such as the midvastus, subvastus, or quadriceps-sparing approach,and of course, a standard medial parapatellar approach.

> The skin incision, unless prior incisions are present, is in the midline slightlymedial to the tibial tubercle to avoid the bony prominence. The incision isstraight although could be curved into varus or valgus if a severe deformity ispresent. Modifying the straight incision will allow the incision to appearstraight once the correction is made. Most arthroplasties can be done withan incision 6 inches (15cm) or less. This usually corresponds toapproximately one fingerbreadth above the superior pole of the patellaending at or just below the tibial tubercle. Larger patients will need largerincisions and the surgeon should lengthen the incision so as not to sacrificeorientation and adequate exposure.

> With a standard tendon splitting medial parapatellar approach, thequadriceps tendon is incised in its medial third from its superior portion,skirting the medial aspect of the patella leaving a small cuff of tissue forsubsequent reattachment. The incision is carried distally approximately 1cmmedial to the patella tendon and carried down at least to the tibial tubercleand further if necessary. An alternative approach would be to bring theincision straight over the medial quarter of the patella and then reflecting thequadriceps tendon from the patella sharply. The distal portion of theincision is the same.

> If the midvastus approach is chosen, the deep incision in the quadricepsexpansion begins approximately 2 to 3cm above the patella. The distalportion is the same as in the above approach, but proximally the vastusmedialis is then split in the line of its fibers for approximately 2 to 3cm. Ineither the medial parapatellar or midvastus approach, the patella is either slidlaterally or everted. In patients with severe deformity and in the obesepatient, the midvastus approach may not provide adequate exposure.

> If the subvastus approach is chosen, the inferior border of the vastus medialisis identified and split away from its distal and posterior attachments and themuscle belly is mobilized proximally and laterally. The medial retinaculum isincised at the medial border of the patella. The distal portion of the incisionis the same as above. Once mobilization is adequate, the patella and entireextensor mechanism can be slid laterally for exposure. With significantdeformity and obesity, this approach may not offer adequate exposure.

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Figure 1

Figure 2

Figure 3

> If the surgeon elects to use a minimally invasive approach, the quadricepssparing approach can be utilized. In this approach, the quadriceps tendon isnot detached at all but rather the medial retinaculum is opened from theproximal patella down to the tibial tubercle. The procedure is done using“moving windows” and MIS instrumentation. Triathlon instrumentation issuitable for all of the above approaches.

> For a knee which has a varus deformity, the next step would be to release themedial collateral ligament back to the posterior-medial corner of the tibia.Depending on the extent of deformity, the deep and superficial medialcollateral ligament can be released, as well as the pes anserinus,semimembranosus, and posterior capsule, to the midline if needed. Therelease of the medial collateral ligament is performed subperiosteally. Therelease is performed in a step-wise fashion releasing only enough to correctthe deformity. The lateral flap including the tissue just medial to the patellatendon is then released up to the patella tendon and the fat pad is incisedacross to the lateral tibial plateau allowing full mobilization of the extensormechanism. The fat pad is trimmed as needed for exposure. The ACL isexcised and the PCL as well (if a PS knee is used). This will allow forexternal rotation of the tibia and anterior translation and/or dislocationforward when needed. If a cruciate-retaining procedure is being performed(CR), then the PCL is not excised. Recession of the PCL is carried out lateron if tightness is demonstrated.

> If the knee has a valgus deformity, a limited ‘release’ of the MCL is carriedout. This usually includes the deep fibers, as well as a small portion of thesuperficial fibers just enough to get back to the posteromedial corner forexposure only. After adequate mobilization of the extensor mechanism, theknee is flexed 90 degrees or more and the patella is everted or slid laterally.Appropriate retractors are placed and the tibia may be subluxed ordislocated anteriorly, or left in situ, depending on surgeon choice andtechnique. Both menisci are excised, as well as all debris from the posteriorrecesses as well as the intracondylar notch. For the valgus knee, the lateralcapsule including the lateral collateral ligament is released back to theposterolateral corner. Further release of the iliotibial band and/or thepopliteus tendon can be performed later if necessary.

> At this point, the knee may well be balanced in extension. If the kneecannot be brought back to neutral alignment, then further medial or lateralrelease may be necessary. The final completed release may be performedafter the bone cuts are made.

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Figure 4

Figure 5

Figure 7

> At this point, the surgeon has the choice as to whether to cut the femur, tibia or patella first.Cutting the tibia first provides more exposure of the posterior femoral condyles. Cutting the femur first provides excellent exposure to the entire plateau and makes proximal resection easier.

>If the patella or tibia is resected early in the procedure, then a patella or tibia bone protector may be applied to prevent damage from retractors or sawblades.

This surgical technique describes cutting the tibia first,followed by the femur and then patella.

Tibial Preparation> The tibia is prepared using the Triathlon

extramedullary alignment system. Retractors areplaced medially, laterally, and posteriorly to exposethe tibial plateau for preparation. All menisci andremaining soft tissues are removed. If the PCL hasbeen retained, a retractor is provided to cradle thePCL for adequate exposure. The knee is flexedanywhere from 45 degrees to more than 90 degrees offlexion depending on surgeon preference. The tibiamay be subluxed or dislocated as required. The tibialresection guide is used to resect the proximal tibia.

> The tibial plateau referencing arm of the proximalrod is placed on the proximal tibia just anterior to theACL insertion. A rongeur may remove anyosteophytes that prevent satisfactory positioning.

Rotational Alignment

> The assembly must be in the proper rotationalalignment. The most common landmark referencedis the tibial tubercle. The assembly should bealigned with the medial third of the tibial tubercle.

> Once the rotational alignment is determined, aheadless pin is placed through the posterior fixationhole in the proximal assembly to lock it in place.Either the anterior or posterior fixation holes maybe used to set the flexion extension and rotationalalignment.


Figure 6

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Varus-Valgus Alignment

> Once the proximal portion of the assembly is fixed, varus-valgusalignment can be attained by adjusting the distal assembly to the propermedial/lateral position. The position should be in the center of the talus,not the center of the ankle. The center of the talus usually resides 5 to10mm medial to the mid-point between the medial and lateral malleoli.

> Medial/lateral offset can be adjusted by pushing the bronze button onthe anterior portion of the distal assembly. 2 Once alignment isachieved, the bronze button is released and the assembly is fixed in place.

> The proper tibial resection should be 0 degrees in the coronal plane ofthe tibia.

Figure 8

Instrument Bar

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Flexion-Extension Alignment

> Once rotational alignment is determined, the ankle clamp is placedproximal to the ankle. The distal assembly locking switch, locatedapproximately halfway up the rod, is then locked. Adjustments to theflexion extension alignment can be made by depressing the buttonlocated on the inferior left hand side of the distal assembly. 1

> Flexion and extension alignment is proper when the long axis of theassembly parallels the weight-bearing axis of the tibia in both the coronaland sagittal planes. Usually, there is less space between the assembly andthe tibia proximally than there is distally. Alignment can be verifiedusing the universal alignment tower and universal alignment rod, whichcan be assembled to the anterior inferior hole on the tibial adjustmenthousing.

> The proper tibial resection should be 0 to 3 degrees in the sagittal plane,depending on surgeon preference and the type of implant used.

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6541-6-700MIS Uncaptured Tibial Resection Guide-Right

6541-6-701MIS Uncaptured Tibial Resection Guide-Left

6541-6-702MIS Captured Tibial Resection Guide-Right

6541-6-703MIS Captured Tibial Resection Guide-Left

6541-2-610Tibial Alignment Distal Assembly EM

6541-2-609Tibial Alignment Ankle Clamp EM

6541-2-429Tibial Stylus

6541-2-807Tibial Alignment Handle

0º slope 6541-2-7043º slope 6541-2-705Tibial Adjustment Housing

6541-6-611MIS Proximal Rod EM

Figure 10

Figure 11

Figure 12

Establishing the Tibial Resection Level

> Once the tibial assembly is fixed in place, the tibialresection level must be established using the tibialstylus. This attaches to the tibial resection guidereferencing either the lowest level of the affectedcompartment or the highest level of the unaffectedcompartment. Typically, in a varus knee, the lateralcompartment is relatively unaffected so placing the“9” referencing end on the unaffected lateral sidewill insure at least a 9mm thickness for the tibialcomponent. If the surgeon desires a thicker tibialcomponent or if there is a defect on the medial sideof the tibia necessitating resection, further resectioncan be made.

> Alternatively, by placing the tibial resection guidewith the “2” referencing end, the resection carriedout would be 2mm lower then the point chosen.For a coarse gross adjustment, the bronze wheel canbe pressed and the assembly slid up or down. Forthe final fine adjustment, the bronze wheel is turnedto the right to move the assembly up the proximalrod or turned left to move the assembly down theproximal rod.

> Once the final position is chosen, two headless pinsare drilled into the “0” neutral holes securing thelevel of the tibial resection guide. For additionalstability, the oblique “X” pinhole can be utilized.Once the tibial resection guide is secured, allalignment instruments are removed.

> Alternatively, one can reference a 14mm resectionoff of the ACL footprint. This correlates with a10mm resection level off of the lateral tibial plateauand an 8mm resection off of the medial tibialplateau.

Final Tibial Resection

> Once all alignment instruments are removed leavingthe tibial resection guide in place, the proximal tibiais osteotomized using either the right or leftcaptured or uncaptured tibial resection guide. If theentire resection cannot be completed, the guide isremoved and the resection completed free-hand.Care must always be taken not to injure the patellatendon or collateral ligaments. Often some bone isleft unresected near the posterior aspect of thelateral tibial plateau and the anterior aspect ofthe lateral tibial plateau near Gerdy’s tubercle.Once the resection guide is removed, final resectioncan be completed either with an oscillating saw or arongeur.


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Figure 13

Instrument Bar

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Preparation of the femur is usually carried out using femoralintramedullary alignment. An extramedullary alignment rodis also provided as a secondary alignment check, as well asfor use when extraarticular deformity is present or thefemoral canal is blocked.

Femoral Preparation

> The intracondylar notch is located and a pointapproximately 1cm anterior to the femoral attachment ofthe posterior cruciate ligament is located. This is slightlymedial to the midline of the femur. If necessary,intracondylar osteophytes can be removed with a chisel orrongeur.

> The 3/8 inch intramedullary drill with a trocar point isattached to the universal driver and a hole is drilled in theintramedullary canal parallel to the shaft of the femur inboth coronal and sagittal plane. Inserting the tapered drillcompletely will create a hole slightly larger than theintramedullary rod to be used. The medullary canal canthen be decompressed with a suction device to helpreduce the incidence of fat or marrow emboli.

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6541-6-611MIS Proximal Rod EM

6541-2-429Tibial Stylus

0º slope 6541-2-7043º slope 6541-2-705Tibial Adjustment Housing

6541-6-700MIS Uncaptured Tibial Resection Guide-Right

6541-6-701MIS Uncaptured Tibial Resection Guide-Left

6541-6-702MIS Captured Tibial Resection Guide-Right

6541-6-703MIS Captured Tibial Resection Guide-Left

3.5'' - 7650-10382.5'' - 7650-1039Headless 1/8'' Pin

6541-4-801Universal Driver

6541-4-5383/8" IM Drill

6541-4-800T-Handle Driver

6541-4-5165/16" IM Rod

Figure 14

Figure 15

Figure 16

> The T-handle driver is attached to the 5/16 inch IM rod. The rod is inserted into the anteriorreferencing femoral alignment assembly.This assembly will facilitate the skim cut of thefemur and then the distal femoral cut. The femoralalignment guide is designed for use on either the leftor right knee and can be set between 2 degrees and 9 degrees of valgus. The desired angle is set bypulling back on the black knob of the femoralalignment guide and placing it in the desired notch.

> Once the angle is set, the rod assembly is slowlyadvanced into the intramedullary canal until itengages the isthmus. The alignment guide is thenplaced flush up against the most prominent distalfemoral condyle.

Before permanently fixing the femoral alignment guide,the rotational position must be confirmed. Thisposition can be referenced in any one of four ways:Whiteside’s line, Epicondylar axis, cut surface of thetibia, or 3 degrees of external rotation. Using morethan one of these four methods is recommended.

Rotational Alignment

Option 1

> Whiteside’s line defines the anterior/posterior axisof the femur and corresponds to the central sulcusof the trochlea. This may be drawn on the femurusing a marker and the jig aligned with it by using 21/8 inch pins in the holes provided. Whiteside’s lineshould be parallel to the pins.

Option 2

> The epicondylar axis is referenced by finding themost prominent portion of the lateral epicondyleand marking it with a marker. The medialepicondyle is less defined. Therefore the synoviumand soft tissue overlying the epicondyle should beremoved so the epicondyle can be identified. Theepicondyle should be outlined with a marker andthe central point located. The medial and lateralreference points are marked and a line is drawn onthe distal femur joining the two.


22

Figure 17

Instrument Bar

23

Option 3

> Proper femoral rotation can also be referenced by orienting theguide parallel to the cut surface of the tibia (this requires that thetibia be cut first, or the line of resection marked). Using thismethod assures the surgeon of a rectangular flexion space.

Figure 18

Option 4

> Rotation can also be set empirically, placing the guide in 3 degrees of external rotation in reference to the posterior femoralcondylar line. This can be easily accomplished using the hangingexternal rotation guide from the femoral alignment guide andaligning the guide parallel to the posterior aspect of both condyles.

Once proper rotation has been set, the headless pins are driventhrough the medial and lateral side of the femoral alignment guide.

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6541-4-800T-Handle Driver

6541-4-5165/16" IM Rod

6541-0-600AR Femoral Alignment Guide

6541-0-601AR Skim Cut Guide

6541-0-6033 Degree Posterior Condylar Reference Guide

3.5'' - 7650-10382.5'' - 7650-1039Headless 1/8'' Pin

Figure 19

Anterior Skim Cut Resection

> The anterior skim cut guide can be applied to thefemoral alignment guide at this point. It is nownecessary to determine the level of resection. This isaccomplished by assembling the skim cut stylus tothe anterior skim cut guide by depressing thesmaller black swing trigger on the skim cut stylusand placing it into the hole on the top surface of theskim cut guide. The guide is then lifted anteriorlyand the stylus is rotated first laterally, then down tothe anterior aspect of the femur.

> Once the satisfactory point is located, the styluspoint is held firmly against the femur and theanterior skim cut guide is secured in that position by tightening both black locking screws using the 1/8 inch hex driver assembly.

> If the surgeon is using an MIS approach and fullvisualization of the anterior femur is not possible,then the tip of the stylus is slid distally to its fulldistal position. It can then be advanced under theskin to its proper position and secured. The lengthof the femoral stylus may be easily adjusted bysliding it to the appropriate position on the anteriorcortex both proximally and distally, as well asmedially and laterally.

> The tip of the stylus will indicate the exit point ofthe saw blade for the provisional skim cut and willalso indicate the point of exit of the final femoralanterior resection when it is made with the femoralresection guide. The exit point can be furtherchecked using a blade runner.

24


> Resected bone from the anterior cortex (Baby-grandpiano shape).

6541-4-5165/16" IM Rod



6541-0-602AR Skim Cut Stylus

6541-4-8021/8" Hex Drive

6541-4-825Slip Torque Handle

6541-4-400Bladerunner

Figure 20

Instrument Bar

25

> The anterior skim cut is then made using .050 inch(1.27mm) blade. The width of the blade isdetermined by surgeon choice. Commonly an 18mm blade is suitable.

> Since rounded posts are built into the medial andlateral walls of the skim cut resection guide toimprove medial and lateral excursion, usually the cutcan be made completely. If it cannot, the resectionguide is removed and the cut is completed free-hand. After the anterior skim cut resection iscomplete, the anterior skim cut resection guide andthe femoral alignment guide is left in place. Nowthat the anterior skim cut has been made, therotational alignment of the femoral component hasbeen finalized.

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Figure 22

Figure 21

Distal Femoral Resection

> Depending on surgeon’s preference, either an 8mmor 10mm distal femoral resection guide is applied tothe anterior skim cut resection guide by aligning theslot on the distal femoral resection guide with thetab on the anterior skim cut resection guide.These guides are magnetized to facilitate assembly.

> Once the anterior bone is removed, assembling thedistal femoral resection guide is facilitated by restingit on the cut surface of the anterior femur and thensliding it into place, connecting it into the anteriorskim cut resection guide. Assembly is also facilitatedby retracting the proximal soft tissues moreproximally. Extension of the knee will also aid inthis maneuver.

> The surgeon may also elect to use the Triathlonmodular handle which connects to the medial holeof the distal resection guide to aid in assembly.In order to assure proper assembly, all bonefragments from the anterior femoral resection mustbe removed.

> Final position is accomplished by pinning the distalfemoral resection guide to the femur using two 1/8 x2.5 inch headless pins. Placing the pins in the holesmarked “0” will allow the surgeon to take 2 or 4mmoff the distal femur later on if necessary. Prior tofinal fixation, an optional external alignment rodmay be applied in order to further check thealignment, especially in the face of an extraarticulardeformity or a blocked femoral canal. The universalalignment tower may be attached to the distalfemoral resection guide and an external alignmentrod is inserted. Correct alignment is achieved whenthe rod intersects the center of the femoral head andis parallel to the axis of the femur in both thecoronal and sagittal planes. The distal portion ofthe rod should exit in the center of the knee.


26

Figure 23

Instrument Bar

27

> Once the distal femoral resection guide is pinned in place,the 1/8 inch pins securing the femoral alignment guide andthe anterior skim cut guide are removed. The IM rod,femoral alignment guide, and anterior skim cut resectionguide are removed from the femur leaving only the distalfemoral resection guide in place. If desired, an 1/8 inch“X” cross pin can be used to prevent the distal cuttingguide from backing off the bone. The distal femur is thenresected using the same blade as for the anterior skim cut.

> Similar to the anterior skim cut resection guide, the distalfemoral resection guide also has rounded posts to increasethe excursion of the blade. If the full distal resectioncannot be accomplished, the guide is removed and the restof the resection is carried out in a free-hand manner.Should an additional 2 or 4 mm of distal femur need to beresected, then the resection guide is replaced over the pinsthrough either the +2 or +4 holes.

> Following resection of the distal femur, all medial andlateral osteophytes are removed to prevent impingementand tenting of the medial or lateral ligament complexes.

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6541-4-808Modular Handle (Optional)



8mm - 6541-0-60810mm - 6541-0-610AR Distal Resection Guide

6541-4-806Universal Alignment Handle

6541-4-602Universal Alignment Rods

3.5'' - 7650-10382.5'' - 7650-1039Headless 1/8'' Pin

Figure 25Figure 24

Figure 26

28


Femoral Sizing

> The proper size for the femoral implant isdetermined by using the anterior referencingfemoral sizer. The wide anterior flange of thefemoral sizer is placed on the resected anteriorfemur and the feet are placed under the femoralcondyles so that one of the feet rests on the mostprominent posterior condyle. The sizer is thenplaced flat against the distal femur. The central postof the sizer will indicate the proper size.

> Since this is an anterior referencing system, theanterior point is fixed and if the size is in-betweentwo sizes, the smaller femoral component may beselected. This assures the proper anterior femoralsize and avoids overstuffing the patellofemoral joint.The medial-lateral width of the femur is also sizedusing the sizing guide on the blade runner. Basedupon the combination of results, the proper size ischosen. The Triathlon implant is designed for animproved medial/lateral and anterior/posterior fit.

> The proper size 4-in-1 cutting block is chosen andthe impactor/extractor is assembled. The cuttingblock is seated flush on to the anterior and distalfemur. Alternatively, the cutting block can be placedagainst the femur by hand. At this point, the size ofthe cutting block is compared to the distal femur.The true medial/lateral size of the implant for thestandard style 4-in-1 cutting block is represented bythe outside edges of the engraved numeralindicating size of the cutting block 1, 2 etc.

> For the MIS 4-in-1 cutting blocks, medial/lateralimplant width is represented by the most medial andlateral extents (nubs) of the cutting block.

Figure 27

Instrument Bar

29

Alternative A/P Sizing Reference

> From the posterior resection plane, the bottoms of the tabson the posterior capture represent the posterior implantthickness and the amount of bone the Triathlon implant willreplace. Sizing is done by sighting across the bottom surfaceof the tabs and comparing that plane with the mostposterior aspect of the femur (typically, on the medialcondyle). The color coded bands in Figure 27 each represent3mm of height and provide sizing information as follows:

4444 Indicates potential laxity of the flexion space.Upsizing may be appropriate.

4444 Indicates that an appropriate size has probablybeen selected.

4444 Indicates potential stuffing of the flexion space.Downsizing may be appropriate.

> The cutting block should be placed centrally on the femuror laterally if some exposed bone is remaining. Care mustbe taken to avoid any significant implant overhang whichcan cause impingement and pain. The blade runner is usedto confirm satisfactory position of the anterior cut toprevent notching. The 7 degree anterior slope of theanterior flange of the Triathlon femoral component reducesthe risks of notching, even when in-between sizes.

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6541-0-620AR Femoral Sizer

# 1 - 6541-0-701# 2 - 6541-0-702# 3 - 6541-0-703# 4 - 6541-0-704# 5 - 6541-0-705# 6 - 6541-0-706# 7 - 6541-0-707# 8 - 6541-0-708AR MIS 4:1 Cutting Block

6541-7-806MIS 4:1 Impactor / Extractor

Figure 28

Figure 29

> Once the size is confirmed, the block should bestabilized with pins medially and laterally, as well asanteriorly if necessary. Once the block is stabilized,the anterior posterior and chamfer cuts are made.

30

> The following order of cuts provides the mostcontinuing stability for the blocks: The posteriorcondyles are resected first followed by the posteriorchamfer, the anterior cortex, and then the anteriorchamfer.

> Prior to any cuts, the blade runner is placed in theanterior cutting slot and the anterior femur isreferenced to assure that the cut will not notch thefemur. If it appears that a notch will occur, then alarger cutting block will be necessary. In the rareevent that not enough femur will be resected, asmaller size will be chosen. A .050 inch saw blade isrecommended.

> The width of the blade will be dictated by the size ofthe patient’s bone. Several passes of the bladeshould be made in order to assure satisfactory flatresection. The block should be checked formovement during and after each cut.

Note: It is imperative that the saw blade be controlledso as not to skive or injure the medial or lateralcollateral ligaments or the patella tendon. With smallincisions, blade excursion must be anticipated.


1 2

3 4

Following posterior condyle and tibial resection, flexion andextension gaps may be assessed and adjustments made, ifneeded. Please refer to the Gap and Ligament Balancingsection on page 34.

Figure 30

Instrument Bar

31

PS Box Preparation

> If the surgeon has chosen a PS knee, then theintercondylar notch must be resected. In order toaccomplish this, the PS box guide is placed onto the distalfemur. This is accomplished using the Femoral TrialImpactor/Extractor. The cutting guide is placed on thedistal femur and impacted in place. Since the width of thedistal portion of the guide represents the exact width ofthe implant, it should be centered and placed in thedesired position flush with the distal resection. The boxguide is then pinned to the femur using the headless pinsthrough the holes on the anterior surface, as well as thedistal surface of the cutting guide.

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6541-7-806MIS 4:1 Impactor / Extractor

# 1 - 6541-0-701# 2 - 6541-0-702# 3 - 6541-0-703# 4 - 6541-0-704# 5 - 6541-0-705# 6 - 6541-0-706# 7 - 6541-0-707# 8 - 6541-0-708AR MIS 4:1 Cutting Block

6541-4-515Headed Nails - 1 1/2"

6541-7-807MIS Femoral Trial Extractor

6541-4-300Headed Nail Impactor Extractor

# 1 - 6541-5-711# 2 - 6541-5-712# 3 - 6541-5-713# 4 - 6541-5-714# 5 - 6541-5-715# 6 - 6541-5-716# 7 - 6541-5-717# 8 - 6541-5-718MIS PS Box Cutting Guide

3.5'' - 7650-10382.5'' - 7650-1039Headless 1/8'' Pin

Figure 31

Figure 32

Figure 33

> The intercondylar region can be resected in twoways. The surgeon may elect to resect the proximalportion of the intracondylar notch using the boxchisel. First, using the inside surfaces of the boxopening as guides, score the posterior cortex on bothsides of the posterior portion of the intercondylarnotch using an oscillating saw. The chisel isassembled to the impaction handle and then thechisel placed within the slot of the box cutting guidewith the surface “distal” towards the distal portion ofthe femur. The chisel is then fully engaged with amallet and left in place. The rest of the box is thencut using either a reciprocating saw or oscillatingsaw. The box chisel is then removed either by handor by using a slap hammer.

> Alternatively, a small reciprocating saw can be usedto resect the medial and lateral borders of theintercondylar notch to the proximal portion of thecutting guide. A thin, narrow oscillating saw is thenused through the proximal slot to resect the distalportion of the femur. The cuts are connected andthe intracondylar bone is removed. Care should betaken to avoid injury to the tibial plateau and eithera retractor should be used to lift the distal femurfrom below or the tibial plateau can be protectedwith the tibial plateau protector provided in theTriathlon instrumentation.

> The 1/8-inch pins are then removed followed byremoval of the PS box cutting guide.

Note: In order to prepare a proper rectangular box,care should be taken not to bias the saw blade.Preparation of a proper rectangular shape will facilitatean accurate implantation of the PS component withminimal bone resection.


32

Figure 34

Instrument Bar

33

> If Modular Femoral Distal Fixation Pegs are to beused, the location holes may be prepared at thisstage using the 1/4" Peg Drill attached to theUniversal Driver. (The peg holes may also beprepared later through the PS Femoral Trial.)

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6541-4-709Box Chisel

6541-4-803Slap Hammer

6541-4-810Impaction Handle

6541-4-5251/4" Peg Drill


3.5'' - 7650-10382.5'' - 7650-1039Headless 1/8'' Pin

6541-4-804Headless Pin Extractor

Figure 35

Figure 36

> To avoid femoral component impingement and toimprove flexion, all osteophytes beyond theposterior condyles as well as those medially andlaterally may be removed with an osteotome.

> Remove the PS Box Cutting Guide with the MISFemoral Trial Impactor / Extractor.

34


Gap and Ligament Balancing

> Once the femur and tibia have been cut, the flexionand extension gaps are assessed. This may beaccomplished using the Triathlon Adjustable SpacerBlock (optional), general Spacer Blocks, or abalancer. A 9mm spacer block may be inserted withthe knee in extension and then in flexion.

> In extension, the knee must come fully straight withsymmetrical stability/laxity. If more than a few mmof laxity is present, a thicker spacer block should beinserted. If laxity is not symmetrical, then furthermedial or lateral release should be carried out.Once stability is satisfactory in extension, with fullextension being achieved, then the spacer block isplaced between the posterior femur and tibialplateau with the knee in 90 degrees of flexion.Similar stability should be accomplished.

> If full extension cannot be achieved, then furtherresection should be considered from the femurand/or the tibia. It must be recognized that furtherresection from the femur will affect only extension.Resection from the tibia will affect both flexion andextension.

> Once the spacer block is inserted in both flexion andextension, a universal alignment rod can be insertedthrough the hole to check alignment. When the gapbalancing and ligament stability are satisfactory,tibial component sizing can be carried out.

Figure 37

Instrument Bar

35

Femoral Trial Assessment

> The femoral impactor extractor is applied to thefemoral trial by inserting the two pegs of theImpactor Extractor into the two peg holes on thetrial. Pegs should be inserted while the handle is inthe unlocked (‘unsqueezed’) position. The trialimplant is then impacted on to the femur. Theimplant is examined to assure that it is flush withthe bone on all cut surfaces. At this point, the backof the knee is examined and any remaining posteriorcondylar bone beyond the trial implant is removedusing an osteotome. The bone is chiseled away andremoved with a pituitary rongeur. Care must betaken not to penetrate the popliteal space as injuryto the neurovascular structures can occur.

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6541-4-610Adjustable Spacer Block




See CatalogPS Femoral Trial

See CatalogCR Femoral Trial

Figure 38

Figure 39

Figure 40

> The assessment of the fit of the femoral trial issimilar for both the CR and PS implants. Theappropriate size and side femoral implant trial isapplied to the femoral trial Impactor/Extractor.The implant is then impacted onto the prepareddistal femur and the Impactor/Extractor isremoved. The fit of the implant is checked toensure that there is a flush fit.

> The Triathlon CR knee has integral medial andlateral femoral pegs. Therefore, if a CR implant ischosen, the 1/4 inch peg drill is assembled to theuniversal driver and distal fixation peg holes aredrilled through the left and condylar right holes.

> The posteriorly stabilized knee does not come withintegral pegs but rather modular capability. Shouldthe surgeon choose to use distal fixation pegs, theholes are drilled in a similar fashion. Once this hasbeen accomplished, the trial may be removed. Atthis point, the tibia, if not already prepared, must beprepared for the tibial implant. Keeping the femoraltrial in place assures adequate exposure, but it maybe removed for tibial preparation if desired.

Tibial Component Sizing

> Retractors are placed to expose the tibial plateau.The femoral trial may be left in place. The universaltibial template is assembled using the alignmenthandle. The assembly is placed on the resected tibialplateau and the appropriate size that fits the tibia ischosen. The implant should contact the cortical rimbut no overhang should exist.


36

Figure 41

Instrument Bar

37

> Once the appropriate size is chosen, two methods of rotationalalignment can be utilized. The first method relies onorientation to the tibial tubercle. The medial third of the tibialtubercle is referenced and the tibial template is aligned usingthe alignment handle.

Figure 42

> Extend the knee to full extension and assess overall alignmentin the A/P and M/L planes.

> A 1/8" drill can be inserted into the lateral hole on the anteriorsurface of the Femoral Trial to aid in alignment.

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See CatalogPS Femoral Trial

See CatalogCR Femoral Trial



# 1 - 6541-2-601# 2 - 6541-2-602# 3 - 6541-2-603# 4 - 6541-2-604# 5 - 6541-2-605# 6 - 6541-2-606# 7 - 6541-2-607# 8 - 6541-2-608Universal Tibial Template

6541-2-807Tibial Alignment Handle

3170-00001/8" Drill

Figure 43

Figure 44

Figure 45

> Once the rotational assessment is determined andthe alignment in the coronal and sagittal plane isconfirmed, the tibial template is fixed to the tibiausing 1/8 inch headed or headless pins.

> Another option is to leave the tibial templateunsecured and apply a trial tibial insert. Once thetibial insert is applied, the knee is placed through arange of motion and the center of the tibial templateis marked on the tibia in extension.

> Regardless of the method used, once the properposition is determined, the tibial template is securedusing the headed or headless pins. Once that isaccomplished, the tibial keel must be prepared.

Tibial Keel Preparation

> The tibial keel punch guide is assembled to theuniversal template by inserting it at a slight angle tothe top of the template into the two locating slots inthe posterior portion of the universal tibial template.The keel punch is then allowed to sit flat on theuniversal tibial template and the handle is pushedforward to lock the keel punch guide to thetemplate.


38

Figure 46

Instrument Bar

39

> Once this is secured, the appropriate size keel punch isplaced into the keel punch guide. A mallet is used toimpact the punch into the tibia.

> If a cemented component is to be used, the keel punchshould be impacted until it fully sits into the guideensuring that it is flat against the bone. If anuncemented implant is used, the surgeon may elect tomake only a slight impression into the tibia, withapproximately 1/3 to 1/2 of the tibial keel punch,allowing for a press-fit of the tibial keel into the tibia.

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# 1 - 6541-2-601# 2 - 6541-2-602# 3 - 6541-2-603# 4 - 6541-2-604# 5 - 6541-2-605# 6 - 6541-2-606# 7 - 6541-2-607# 8 - 6541-2-608Universal Tibial Template

3.5'' - 7650-10382.5'' - 7650-1039Headless 1/8'' Pin

6541-4-575Headed Nails - 3/4"

6541-4-515Headed Nails - 1 1/2"

6541-4-300Headed Nail Impactor Extractor

Size 1, 2, 3 - 6541-2-713Size 4, 5, 6, 7, 8 - 6541-2-748Keel Punch Guide

Sizes 1, 2, 3 - 6541-2-013Sizes 4, 5, 6 - 6541-2-046Sizes 7, 8 - 6541-2-078Keel Punch

Size 1, 2, 3 - 6541-2-113Size 4, 5, 6 - 6541-2-146Size 7, 8 - 6541-2-178Low Profile Keel Punch

6541-4-804Headless Pin Extractor

Figure 47

Figure 48

> Once the desired depth is achieved, the keel punchguide handle is lifted up and rotated anteriorly. Thehandles of the Keel Punch Guide and Keel Punch arethen squeezed together to cantilever the punch outof the tibia. The Keel Punch is removed along withthe Keel Punch Guide.

Trial Reduction

> Sequential trial inserts are used to confirm thatfull extension is achieved as well as satisfactoryflexion. The Triathlon Total Knee System allowsfor hyperextension of 5 degrees with flexiongreater than 150 degrees. This degree of motionmay not be achieved because of tightness of thequadriceps mechanism or the size of the patient’sthigh. Stability in flexion and extension is verified.

> Once the appropriate tibial insert is identified, it isleft in place and the patella is prepared.

It is important not to overstuff the patellofemoral joint.Anterior referencing assures that overstuffing will notoccur on the femoral side. In order not to overstuff onthe patella side, the patella/implant construct should beless than or equal to the original thickness of the patellaand its cartilage (present or eroded), but never thicker.

Patella Preparation

> The thickness of the patella should be determined byusing the patella caliper. Once the thickness isdetermined and the approximate width is estimated,the surgeon can determine the thickness of thecomponent to be used. The Triathlon patellaimplant becomes somewhat thicker with increasedwidth. Implants range from 8 to 11mm of thicknessand width from 29 to 40mm.


40

Figure 49

Instrument Bar

41

> Patella preparation is facilitated by placing the leg infull extension. The patella can be prepared byturning either 90 degrees or up to 180 degrees.

> The surgeon can elect to prepare the patella byremoving a predetermined amount of bone or byallowing a predetermined amount of bone toremain. If the surgeon chooses the bone-removingmethod, the surgeon measures the patella thicknessand determines how much bone will be resectedfrom the native patella. The patella clamp is appliedto the patella in a position so that more medial facetwill be removed than lateral facet, assuring asymmetrical residual bone. The patella stylusswivels to be able to sweep over the highest portionof the articular surface determining the appropriatelevel for resection.

> The amount of resection is set on the stylus bypressing the gold button and moving the body of thestylus to the resection line. Once this isaccomplished, the patella clamp is secured aroundthe patella. The resection is made through one ofthe resection slots.

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Size 1, 2, 3 - 6541-2-713Size 4, 5, 6, 7, 8 - 6541-2-748Keel Punch Guide

Sizes 1, 2, 3 - 6541-2-013Sizes 4, 5, 6 - 6541-2-046Sizes 7, 8 - 6541-2-078Keel Punch

Size 1, 2, 3 - 6541-2-113Size 4, 5, 6 - 6541-2-146Size 7, 8 - 6541-2-178Low Profile Keel Punch

6541-3-602Patella Caliper

6541-3-702Small Patella Clamp Jaw Right

6541-3-703Small Patella Clamp Jaw Left

6541-3-601Patella Stylus

6541-3-600Patella Clamp

Figure 50

Figure 51

> The surgeon may also elect to use the bone-remaining method. With this technique, the patellaclamp is assembled and the patella stylus is attachedto the hex shaped hole on either jaw by squeezingthe gold tab. The patella stylus will determine howmuch bone will remain. The desired resectionamount is set on the patella stylus by pressing thegold bar and removing the body of the patella stylusto the resection line. The patella clamp is closedaround the patella. Residual bone should be at least12mm in order to reduce the possibility of patellafracture. Once the proper position is secured, theresection is carried out through one of the resectionslots.

> The clamp is then removed.


Figure 52

42

Figure 53

Instrument Bar

43

Figure 54

> At this point, the medial/lateral width of the patella ismeasured and the appropriate size patella template ischosen. Care should be taken to avoid any overhang.Any degree of overhang can cause anterior knee painby impingement.

> Once the appropriate size template is applied, theclamp is secured and the patella drill is used to drill thethree holes of the patella. The drill is engaged to thefull depth. Once all three drill holes are made, thepatella clamp is removed by depressing the releasetrigger.The template is also released by pressing thegold button.

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27mm - 6541-3-62729mm - 6541-3-62931mm - 6541-3-63133mm - 6541-3-63336mm - 6541-3-63639mm - 6541-3-639Symmetric Patella Drill Template

29mm - 6541-3-61732mm - 6541-3-61835mm - 6541-3-61938mm - 6541-3-62040mm - 6541-3-621Asymmetric Patella Drill Template

6541-3-801Patella Clamp Base

6541-3-524All-Poly Patella Drill w/Stop



Figure 55

Patella Trial Assessment

> Once the patella has been drilled, the patella trial isapplied. If there is any overhang, a smaller implantis chosen. The surgeon can elect to use either asymmetric or asymmetric implant. An asymmetricimplant improves patella tracking by medializing thedome of the patella.

> The patella trial is applied and the knee is placedthrough a range of motion. It is acceptable to placea tenaculum on the edge of the quadriceps tendonand pull proximally to stabilize the extensormechanism especially if one has used a tendonsplitting medial parapatella approach. No externalpressure should be applied nor should any medialforce be applied.

> The patella should track satisfactorily throughoutthe range of motion without any tilting orsubluxation. If tilting or subluxation occurs, therotation and alignment of the femoral and tibialcomponents should be checked. If they aresatisfactory, a lateral retinacular release should beconsidered. Prior to a lateral retinacular release, thesurgeon could consider deflating the tourniquet toreduce any external pressure on the quadricepsmechanism causing ‘false’ subluxation.

> Once patella tracking has been determined to besatisfactory, final implantation may beaccomplished.

Final Preparation and ImplantationThe trial components are removed. The knee should bethoroughly irrigated of all debris. This may be bestaccomplished by a pulsating lavage. If cementedimplants are used, the bone may be further preparedusing a hemostatic agent and then dried again. Any“high” spots may be removed using an osteotome,oscillating saw, or bone file.

Tibia

> Cementless: The knee is flexed and the tibia isexposed with appropriate retractors. The peri-apatite coated tibial implant is then impacted intothe tibia. The implant must be stable and flush withthe bone, with no gaps present.

> Cemented: A batch of methyl-methacrylate Simplexcement is mixed. The tibial component is coatedwith cement, as well as the upper tibia and the keelpunch area. The tibial component is impacted andexcess cement is removed.


Figure 56

Figure 57

44

Figure 58

Figure 59

Femur

> Cementless: The femoral component is impacted, againassuring that the implant is flush with the bone with nogaps. Care must be taken to avoid scratching any of thereal implants. If there is any question about stability ofthe implants, a cemented implant should be considered.

> Cemented: Cement is applied to the femoralcomponent and the cut surface of the femur and thefemoral component is impacted. Excess cement isremoved.

> Posterior Stabilized Knee: If Modular Femoral DistalFixation Pegs are to be used, assemble the pegs to theFemoral Component using the 1/8'' Hex Drive and theSlip Torque Handle prior to implantation.

Instrument Bar

45

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6541-4-807Femoral Impactor Extractor


See CatalogPS Femoral Component - Cemented

See CatalogCR Femoral Component - Cemented

6541-4-8021/8" Hex Drive

6541-4-825Slip Torque Handle

See CatalogModular Femoral Distal Fixation Pegs

6541-4-805Baseplate Impactor/Extractor

6541-4-811Femoral Impactor

6541-4-812Tibial Baseplate Impactor

See CatalogPrimary Tibial Baseplate - Cemented

See CatalogLow Profile Tibial Baseplate

6541-7-811MIS Femoral Flexion Impactor

CR or PS Tibial Insert

> The trial tibial component is applied to the tibia andthe knee is then placed through a range of motion tocheck the stability, kinematics, range of motion, andpatella tracking. If all is satisfactory, the trialcomponent is removed and an implant tibial insertis applied. Bringing the leg into 45 degrees offlexion may help engage the posterior lockingfeatures of the insert.

Figure 60

Figure 61

Figure 62

46

Symmetric or Asymmetric Patella

> Cementless: The peri-apatite coated patellar implantis pressed into the patella using the patella clamp.The implant must be stable and flush with the bone.

> Cemented: The cement is applied to both theimplant and the cut surface of the bone and theimplant applied and held with the patella clamp.All excess cement is removed. After the cement ishard, the clamp is removed and the knee is againexamined.


Closure

> The knee is then reduced and again placed througha range of motion where all aspects are checkedagain. Once the surgeon is satisfied with thereconstruction, the knee is closed in a routinefashion. A drain may or may not be used at thesurgeon’s discretion. The quadriceps expansion isthen repaired using strong interrupted slowlyabsorbable sutures. The subcutaneous tissue isclosed with smaller absorbable suture, and the skinis closed with surgical staples or sutures. Thewound is cleansed, dried and a large bulky dressingis applied. The tourniquet is deflated.

Instrument Bar

47

Com

ponent

Impla

nta

tion

Rehabilitation

> The Triathlon Total Knee System has been designedfor early recovery. Depending on surgeonpreference, patients may be instructed to be fullyweight-bearing and allowed to perform full range ofmotion exercises as early as tolerated.


6541-4-813Tibial Insert Impactor

See CatalogPS Tibial Insert

See CatalogCR Tibial Insert

6541-3-800Patella Cement Cap

See CatalogSymmetric Patella

See CatalogAsymmetric Patella

6541-3-801Patella Clamp Base


48

AR MIS Miscellaneous Instruments Kit Contents

MIS AR Size 1, 2, 7, 8 4:1 Cutting Block Mini Case Kit Contents

Total Quantity 32

Total Quantity 5


3170-0000 1/8" Drill 1

6541-4-300 Headed Pin Impactor Extractor 1

6541-4-400 Bladerunner 1

6541-4-515 Headed Nails- 1 1/2" 2

6541-4-516 5/16" IM Rod 1

6541-4-525 1/4" Peg Drill 1

6541-4-538 3/8" IM Drill 1

6541-4-575 Headed Nail- 3/4" 2

6541-4-602 Universal Alignment Rod 1

6541-4-610 Adjustable Spacer Block 1

6541-4-709 Box Chisel 1

6541-4-800 T- Handle Driver 1

6541-4-801 Universal Driver 1

6541-4-802 1/8" Hex Drive 1

6541-4-803 Slap Hammer 1

6541-4-804 Headless Pin Extractor 1

6541-4-805 Baseplate Impactor Extractor 1

6541-4-806 Universal Alignment Handle 1

6541-4-807 Femoral Impactor Extractor 1

6541-4-808 Modular Handle 1

6541-4-809 Headless Pin Driver 1

6541-4-810 Impaction Handle 1

6541-4-811 Femoral Impactor 1

6541-4-812 Tibial Baseplate Impactor 1

6541-4-813 Tibial Insert Impactor 1

6541-4-825 Slip Torque Handle 1

6541-8-004 Miscellaneous Instruments - Upper Tray 1

6541-8-104 Miscellaneous Instruments - Lower Tray 1

6541-9-000 Triathlon Case 1

QIN 4333 Package Insert 1

Catalog # Description Quantity in Kit

6541-0-701 Triathlon AR 4:1 Cutting Block - Size 1 1




6541-9-410 Triathlon AR 4:1 Mini Case 1


5550-T-278 Symmetric Patella 27mm x 8mm 1






5551-T-299 Asymmetric Patella 29mm(S/I) x 33mm(M/L) x 9mm 1





6541-3-524 All-Poly Patella Drill w/ Stop 1

6541-3-600 Patella Clamp 1

6541-3-601 Patella Stylus 1

6541-3-602 Patella Caliper 1

6541-3-617 Asymmetric Patella Drill Template - 29mm 1





6541-3-627 Symmetric Patella Drill Template - 27mm 1






6541-3-702 Small Patella Clamp Jaw Right 1

6541-3-703 Small Patella Clamp Jaw Left 1

6541-3-800 Patella Cement Cap 1

6541-3-801 Patella Clamp Base 1

6541-8-005 Patella Preparation and Trialing - Upper Tray 1

6541-8-105 Patella Preparation and Trialing - Lower Tray 1



*S/I = Superior/Inferior 49

Patella Preparation and Trialing Kit Contents

Total Quantity 34

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AR MIS Size 3-6 Femoral & Tibial Preparation Kit Contents

Total Quantity 38



7650-1038 Headless 1/8" Pin – 3.5" 4

7650-1039 Headless 1/8" Pin – 2.5" 1

6541-0-600 Triathlon AR Femoral Alignment Guide 1

6541-0-601 Triathlon AR Skim Cut Guide 1

6541-0-602 Triathlon AR Skim Cut Stylus 1

6541-0-603 Triathlon AR 3 Degree Posterior Condylar Reference Guide 1

6541-0-608 Triathlon AR Distal Resection Guide - 8mm 1

6541-0-610 Triathlon AR Distal Resection Guide - 10mm 1

6541-0-620 Triathlon AR Femoral Sizer 1





6541-0-936 Triathlon AR 3-6 Femoral Tibial Prep Lower Tray 1

6541-2-013 Size 1-3 Keel Punch 1

6541-2-046 Sizer 4-6 Keel Punch 1

6541-2-429 Tibial Stylus 1

6541-2-603 #3 Universal Tibial Template 1




6541-2-609 Tibial Alignment Ankle Clamp EM 1

6541-2-610 Tibial Alignment Distal Assembly EM 1

6541-2-704 Tibial Adjustment Housing - 0 Degree Slope 1

6541-2-705 Tibial Adjustment Housing - 3 Degree Slope 1

6541-2-713 Size 1-3 Keel Punch Guide 1

6541-2-748 Size 4-8 Keel Punch Guide 1

6541-2-807 Tibial Alignment Handle 1

6541-6-611 MIS Proximal Rod EM 1

6541-7-806 MIS 4:1 Impactor / Extractor 1

6541-7-807 MIS Femoral Trial Extractor 1

6541-7-811 MIS Femoral Flexion Impactor 1

6541-8-030 MIS Size 3-6 Femoral & Tibial Preparation - Upper 1



MIS Tibial Resection Guides (Either Captured or Uncaptured Required)

Total Quantity 4

6541-6-700 MIS Uncaptured Tibial Resection Guide - Right 1

6541-6-701 MIS Uncaptured Tibial Resection Guide - Left 1

6541-6-702 MIS Captured Tibial Resection Guide - Right 1

6541-6-703 MIS Captured Tibial Resection Guide - Left 1

51

Size 3-6 PS Femoral & Tibial Trialing Kit Contents

Total Quantity 36

*S/I = Superior/Inferior


5511-T-301 PS Femoral Trial #3 Left 1

5511-T-302 PS Femoral Trial #3 Right 1

5511-T-401 PS Femoral Trial #4 left 1






5532-T-309 PS Tibial Insert Trial #3-9MM 1




















6541-5-713 #3 PS Box Cutting Guide 1




6541-8-009 Size 3-6 Femoral and Tibial Trialing- Upper Tray 1

6541-8-109 Size 3-6 PS Femoral and Tibial Trialing-Lower Tray 1



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MIS AR Size 1, 8 PS Preparation & Trialing Kit Contents

Total Quantity 19

5511-T-101 PS Femoral Trial # 1Left 1

5511-T-102 PS Femoral Trial # 1Right 1

5511-T-801 PS Femoral Trial # 8 Left 1

5511-T-802 PS Femoral Trial # 8 Right 1

5532-T-109 PS Tibial Insert Trial # 1 - 9mm 1










6541-2-601 #1 - Universal Tibial Template 1




6541-8-113 1-8 PS Lower Tray 1

52



MIS AR Size 2, 7 PS Preparation & Trialing Kit Contents

Total Quantity 22

5511-T-201 PS Femoral Trial #2 Left 15511-T-202 PS Femoral Trial #2 Right 15511-T-701 PS Femoral Trial #7 Left 15511-T-702 PS Femoral Trial #7 Right 15532-T-209 PS Tibial Insert Trial # 2- 9MM 15532-T-211 PS Tibial Insert Trial # 2 -11MM 15532-T-213 PS Tibial Insert Trial # 2 -13MM 15532-T-216 PS Tibial Insert Trial # 2 -16MM 15532-T-219 PS Tibial Insert Trial # 2 -19MM 15532-T-709 PS Tibial Insert Trial # 7 -9MM 15532-T-711 PS Tibial Insert Trial # 7 -11MM 15532-T-713 PS Tibial Insert Trial # 7 -13MM 15532-T-716 PS Tibial Insert Trial # 7 -16MM 15532-T-719 PS Tibial Insert Trial # 7 -19MM 16541-5-712 #2 MIS PS Box Cutting Guide 16541-5-717 #7 MIS PS Box Cutting Guide 16541-2-078 Size 7-8 Keel Punch 16541-2-602 #2 Universal Tibial Template 16541-2-607 #7 Universal Tibial Template 16541-8-022 2,7 PS Preparation and Trialing- Upper Tray 16541-9-000 Triathlon Case 1QIN 4333 Package Insert 1


Size 3-6 CR Femoral & Tibial Trialing Kit Contents

Total Quantity 32

5510-T-301 CR Femoral Trial #3 Left 1

5510-T-302 CR Femoral Trial #3 Right 1







5530-T-309 CR Tibial Insert Trial # 3 -9MM 1






5530-T-411 CR Tibial Insert Trial #4 -11MM 1










5530-T-611 CR Tibial Insert Trial #6 -11MM 1




6541-8-008 Size 3-6 CR Femoral and Tibial Trialing- Upper Tray 1

6541-8-108 Size 3-6 CR Femoral and Tibial Trialing- Lower Tray 1



Low Profile Tibial Tray Keel Punch Kit Contents

Total Quantity 3

6541-2-113 Size 1-3 MIS Keel Punch 16541-2-146 Size 4-6 MIS Keel Punch 16541-2-178 Size 7-8 MIS Keel Punch 1

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MIS AR Size 2, 7 CR Preparation & Trialing Kit Contents

Total Quantity 20

5510-T-201 CR Femoral Trial #2 Left 15510-T-202 CR Femoral Trial #2 Right 15510-T-701 CR Femoral Trial #7 Left 15510-T-702 CR Femoral Trial #7 Right 15530-T-209 CR Tibial Insert Trial # 2 -9MM 15530-T-211 CR Tibial Insert Trial # 2 -11MM 15530-T-213 CR Tibial Insert Trial # 2 -13MM 15530-T-216 CR Tibial Insert Trial # 2 -16MM 15530-T-219 CR Tibial Insert Trial # 2 -19MM 15530-T-709 CR Tibial Insert Trial # 7 -9MM 15530-T-711 CR Tibial Insert Trial # 7 -11MM 15530-T-713 CR Tibial Insert Trial # 7 -13MM 15530-T-716 CR Tibial Insert Trial # 7 -16MM 15530-T-719 CR Tibial Insert Trial # 7 -19MM 16541-2-078 Size 7-8 Keel Punch 16541-2-602 #2 Universal Tibial Template 16541-2-607 #7 Universal Tibial Template 16541-8-021 2,7 CR Preparation and Trialing- Upper Tray 16541-9-000 Triathlon Case 1QIN 4333 Package Insert 1

54


MIS AR Size 1, 8 CR Preparation & Trialing Kit Contents


Total Quantity 17

5510-T-101 CR Femoral Trial # 1 Left 1

5510-T-102 CR Femoral Trial # 1 Right 1

5510-T-801 CR Femoral Trial # 8 Left 1

5510-T-802 CR Femoral Trial # 8 Right 1

5530-T-109 CR Tibial Insert Trial #1 - 9mm 1












6541-8-112 1-8 CR Lower Tray 1


Size 1-8 Max PS Tibial Trialing Kit Contents

Total Quantity 18

5532-T-122 PS Femoral Trial # 1 - 22mm 1
















6541-8-120 Triathlon 1-8 Max PS - Upper Tray 1


Primary Tibial Baseplate - Cemented Part Numbers

Low Profile Tibial Baseplate - Cemented Part Numbers

5520-B-100 Low Profile Tibial Baseplate – Cemented #1








5520-M-100 Low Profile Baseplate #1








55

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Primary Tibial Baseplate - Beaded Part Numbers

Primary Tibial Baseplate - Beaded with Peri-Apatite Part Numbers

Catalog # Description Cementless

Catalog # Description Cemented

5523-B-100 Primary Tibial Baseplate - Beaded - #1








5526-B-100 Primary Tibial Baseplate - Beaded w/PA - #1








PS Femoral Component - Cemented Part Numbers

5515-F-101 PS Femoral Component – Cemented #1 Left

5515-F-102 PS Femoral Component – Cemented #1 Right















PS Femoral Cementless Component - Beaded Part Numbers

PS Femoral Cementless Component - Beaded with Peri-Apatite Part Numbers


5514-F-101 PS Femoral Component - Beaded - #1, Left

5514-F-102 PS Femoral Component - Beaded - #1, Right















5516-F-101 PS Femoral Component - Beaded w/PA - #1, Left

5516-F-102 PS Femoral Component - Beaded w/PA - #1, Right















57

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CR Femoral Component - Cemented Part Numbers

5510-F-101 CR Femoral Component – Cemented #1 Left

5510-F-102 CR Femoral Component – Cemented #1 Right















CR Femoral Cementless Component - Beaded Part Numbers

5513-F-101 CR Femoral Component - Beaded - #1, Left

5513-F-102 CR Femoral Component - Beaded - #1, Right
















Catalog # Description Cemented

CR Femoral Cementless Component - Beaded with Peri-Apatite Part Numbers

5517-F-101 CR Femoral Component - Beaded w/PA - #1, Left

5517-F-102 CR Femoral Component - Beaded w/PA - #1, Right
















59

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Catalog # Description

PS Tibial Insert Part Numbers

Continued Note: 5532-P-109 through 5532-P-125 are not available for sale in the US.

5532-P-109* PS Tibial Insert #1 – 9mm5532-P-111* PS Tibial Insert #1 – 11mm5532-P-113* PS Tibial Insert #1 – 13mm5532-P-116* PS Tibial Insert #1 – 16mm5532-P-119* PS Tibial Insert #1 – 19mm5532-P-122* PS Tibial Insert #1 – 22mm5532-P-125* PS Tibial Insert #1 – 25mm

5532-P-209 PS Tibial Insert #2 – 9mm5532-P-211 PS Tibial Insert #2 – 11mm5532-P-213 PS Tibial Insert #2 – 13mm5532-P-216 PS Tibial Insert #2 – 16mm5532-P-219 PS Tibial Insert #2 – 19mm5532-P-222 PS Tibial Insert #2 – 22mm5532-P-225 PS Tibial Insert #2 – 25mm






PS Tibial Insert Part Numbers - Continued



PS Tibial Insert - X3 Part Numbers

5532-G-109 PS Tibial Insert - X3 # 1 - 9mm





















Continued

61

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PS Tibial Insert - X3 Part Numbers - Continued




































CR Tibial Insert - X3 Part Numbers

5530-G-109 CR Tibial Insert - X3 # 1 - 9mm5530-G-111 CR Tibial Insert - X3 # 1 - 11mm5530-G-113 CR Tibial Insert - X3 # 1 - 13mm5530-G-116 CR Tibial Insert - X3 # 1 - 16mm

5530-G-119 CR Tibial Insert - X3 # 1 - 19mm
















63

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CR Tibial Insert Part Numbers

5530-P-109 CR Tibial Insert #1 – 9mm5530-P-111 CR Tibial Insert #1 – 11mm5530-P-113 CR Tibial Insert #1 – 13mm5530-P-116 CR Tibial Insert #1 – 16mm5530-P-119 CR Tibial Insert #1 – 19mm








Symmetric Patella Part Numbers

Asymmetric Patella Part Numbers

* S/I = Superior/Inferior

Modular Femoral Distal Fixation Peg Part Number

5550-L-278 Symmetric Patella S27mm x 8mm






5551-L-299 Asymmetric Patella A29mm (S/I*) x 9mm





5575-X-000 Modular Femoral Distal Fixation Peg (2 per pack)

Symmetric Patella - X3 Part Numbers

5550-G-278 Symmetric Patella - X3 - S27mm x 8mm







Asymmetric Patella - X3 Part Numbers

5551-G-299 Asymmetric Patella - X3 - A29mm (S/I*) x 9mm





Asymmetric Metal-Backed Patella - Beaded with Peri-ApatitePart Numbers

5554-L-320 Asymmetric Metal-Backed Patella-Beaded w/PA-A32mmx10mm




65

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Notes



Warnings and Precautions

IndicationsGeneral Total Knee Arthroplasty (TKR) Indicationsinclude:• Painful, disabling joint disease of the knee resulting

from non-inflammatory degenerative joint disease(including osteoarthritis, traumatic arthritis oravascular necrosis) or rheumatoid arthritis.

• Post-traumatic loss of knee joint configuration andfunction.

• Moderate varus, valgus, or flexion deformity in whichthe ligamentous structures can be returned toadequate function and stability.

• Revision of previous unsuccessful knee replacement orother procedure.

• Fracture of the distal femur and/or proximal tibia thatcannot be stabilized by standard fracture managementtechniques.

Contraindications• Any active or suspected latent infection in or about the

knee joint.• Distant foci of infection which may cause

hematogenous spread to the implant site.• Any mental or neuromuscular disorder which would

create an unacceptable risk of prosthesis instability,prosthesis fixation failure, or complications inpostoperative care.

• Bone stock compromised by disease, infection or priorimplantation which cannot provide adequate supportand/or fixation to the prosthesis.

• Skeletal immaturity.• Severe instability of the knee joint secondary to the

absence of collateral ligament integrity and function.• Obesity. An overweight or obese patient can produce

loads on the prosthesis which can lead to failure of thefixation of the device or to failure of the device itself.

See package insert for warnings, precautions, adverseeffects and other essential product information.

Adverse Effects• While the expected life of total knee replacement

components is difficult to estimate, it is finite. Thesecomponents are made of foreign materials which areplaced within the body for the potential restoration ofmobility or reduction of pain. However, due to themany biological, mechanical and physicochemicalfactors which affect these devices but cannot beevaluated in vivo, the components cannot be expectedto indefinitely withstand the activity level and loads ofnormal healthy bone. Surgeons should counselpatients against having unrealistic expectations aboutthe lifetime of the device.

• Dislocation of the femoral, tibial, or patellar prosthesiscan occur due to inappropriate patient activity, traumaor other biomechanical considerations.

• Loosening of total knee components can occur. Earlymechanical loosening may result from inadequateinitial fixation, latent infection, premature loading ofthe prosthesis, component malalignment or trauma.Late loosening may result from trauma, infection,biological complications including osteolysis, ormechanical problems, with the subsequent possibilityof bone erosion and/or pain.

• Fatigue fracture of total knee components, includingtibial, femoral and patellar components, has occurredin a small percentage of cases. Knee componentfracture may result due to inadequate support of thecomponent by the underlying bone or poorcomponent fixation.

• Peripheral neuropathies, nerve damage, circulatorycompromise and heterotopic bone formation mayoccur.

• Serious complications may be associated with any total joint replacement surgery. These complicationsinclude, but are not limited to genitourinary disorders;gastrointestinal disorders; vascular disorders, includingthrombus; bronchopulmonary disorders, includingemboli; myocardial infarction or death.

• Wear of polyethylene components has occurred and

literature reports have associated its occurrence withbone resorption, loosening and infection.

• Metal sensitivity reactions have been reportedfollowing joint replacement.

• Adverse effects may necessitate reoperation, revision,arthrodesis of the involved joint, and/or amputationof the limb.

• Soft tissue imbalance and/or laxity has been related tocomponent malalignment, which may result in earlywear and/or failure of the implant.

• With all implant devices, asymptomatic, localizedprogressive bone resorption (osteolysis) may occuraround the prosthetic components as a consequenceof foreign-body reaction to the particulate matter ofcement, metal, ultra-high molecular weightpolyethylene (UHMWPE) and/or ceramic. Particulateis generated by interaction between components, aswell as between components and bone, primarilythrough wear mechanisms of adhesion, abrasion andfatigue. Secondarily, particulate can also be generatedby third-body wear. Osteolysis can lead to futurecomplications, including loosening, necessitating theremoval and replacement of prosthetic components.

• It is known that very small particles from metal andpolyethylene components can be shed from thecomponent during normal use and over time.Although most of this debris stays in the relevantjoint (e.g., contained in the synovium) or is trappedby surrounding scar tissue, microscopic particles canpossibly travel or migrate outside of the joint todifferent parts of the body. Currently, there areunanswered questions about debris and microscopicparticles that can be generated from thesecomponents. It has been shown that microscopicdebris particles can be disseminated (migrate)throughout the body and on occasion have beendescribed as accumulating in lymph nodes and otherparts of the body. Although to date no significantmedical complications have been reported as a resultof these particles, their migration and/oraccumulation in the body have been described in theliterature. Given the insufficient time period duringwhich patients with these devices have been followedand the fact that these devices are currently beingused in younger patients and remain in the body forincreasingly longer periods of time, it should be saidthat the long-term effects, if any, from these particles,is unknown. The long-term effects that have beentheorized include:– Cancer: There is presently no scientific evidence

that links metallic or polyethylene debris withcancer. However, the possibility cannot be ruled out.

– Lymphadenopathy and Accumulation in OtherTissues/Organs: There have been a few reports ofthe accumulation of wear debris in lymph nodes(proximate and distal). Although no medicalcomplications or disease process has been reportedas stemming from these accumulations, theirexistence should be recognized to facilitatediagnosis and avoid confusion with suspiciouslesions, cancerous or otherwise.

– Systemic Disease: There has been some speculationthat there could be an association betweenmigration of debris and as yet unspecified systemiceffects. No case studies or other reports have beenpublished suggesting any such possibility. Again,given the limited time period during which patientsreceiving these implants have been followed, itcannot be scientifically proven that some long-termeffect may not show up in the future. Given thedearth of scientific data suggesting any associationis by the use of these materials for several decades, itis strongly believed that the benefits of these devicesclearly outweigh the potential risks for any suchtheoretical long-term effect.

Patient CounselingSurgeons should discuss all relevant contraindications,adverse effects and the need for post-implantationprotection with their patients.

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325 Corporate DriveMahwah, NJ 07430t: 201 831 5000

www.stryker.com

A surgeon must always rely on his or her own professional clinical judgment when deciding to use whichproducts and/or techniques on individual patients. Stryker is not dispensing medical advice and recommendsthat surgeons be trained in orthopaedic surgeries before performing any surgeries.

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings.Always refer to the package insert, product label and/or user instructions before using any Stryker product.Products may not be available in all markets. Product availability is subject to the regulatory or medical practicesthat govern individual markets. Please contact your Stryker representative if you have questions about theavailability of Stryker products in your area.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for thefollowing trademarks or service marks: Triathlon and Simplex. All other trademarks are trademarks of theirrespective owners or holders.

Literature Number: LSPK45MS/GS 1.5m 12/06

Copyright © 2006 StrykerPrinted in USA

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