VERILAST™ - Smith & Nephew. Biomech, 2005;38(2):357-365. 2. A. Parikh, M. Morrison and S. Jani,...

VERILAST™Oxidized Zirconium with XLPE

A technology from

From a wear perspective, all implants with conventional material technologyperform about the same. XLPE material technologies significantly improve thewear, but the wear rates across implants are still essentially the same. However,VERILAST Technology addresses the entire bearing couple and has the lowestpublished wear rate with testing of 45 million cycles.

Wear Performance

1. H. M. J. McEwen, P. I. Barnett, C. J. Bell, R. Farrar, D. D. Auger, M. H. Stone and J. Fisher, The influence of design, materials and kinematics on the in vitro wear of total knee replacements, J. Biomech, 2005;38(2):357-365.2. A. Parikh, M. Morrison and S. Jani, Wear testing of crosslinked and conventional UHMWPE against smooth and roughened femoral components, Orthop Res Soc, San Diego, CA, Feb 11-14, 2007, 0021.3. AA. Essner, L. Herrera, S. S. Yau, A. Wang, J. H. Dumbleton and M. T. Manley, Sequentially crosslinked and annealed UHMWPE knee wear debris, Orthop Res Soc, Washington D.C., 2005, 71.4. L. Herrera, J. Sweetgall, A. Essner and A. Wang, “Evaluation of sequentially crosslinked and annealed wear debris, World Biomater Cong, Amsterdam, May 28-Jun 1, 2008, 583.5. C. Schaerer, K. Mimnaugh, O. Popoola and J. Seebeck, “Wear of UHMWPE tibial inserts under simulated obese patient conditions,” Orthop Res Soc, New Orleans, LA, Feb 6-10, 2010, 2329.6. Biomet publication, FDA Cleared Claims for E1 Antioxidant Infused Technology”7. Ref: DePuy Attune 510 K Document K101433 Dec 10, 20108. R. Papannagari, G. Hines, J. Sprague and M. Morrison, “Long-term wear performance of an advanced bearing knee technology,” ISTA, Dubai, UAE, Oct 6-9, 2010.9. Ref: Smith & Nephew OR-07-17610. Ref: Smith & Nephew OR-12-129

*ISO 14243-1 testing protocol used. Other results obtained using ISO 14243-3 protocol

VERILAST Technology demonstrates lower wear rates thanother XLPE formulations using very similar test conditions

Mean volumetric wear rates of CoCr against conventional polyethylene (CPE),CoCr against crosslinked polyethylene (XLPE) and OXINIUM™ against XLPE aspublished by the respective companies with their respective implants.

40

50

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35

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™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

VERILAST Technology vs Conventional, XLPE and Anti-oxidant Technologies

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ate

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Smith & Nephew GmbHAdvanced Surgical DevicesMainstraße 2, 45768 Marlwww.smith-nephew.com Lit. Nr. 01799 Ed. 05/14


• OXINIUM™ Oxidized Zirconium is an advanced bearing material that combines the strength of metal with the wear resistance of ceramics

• OXINIUM Technology is more than twice as hard as CoCr and will betterresist abrasion compared to CoCr2

• OXINIUM Technology has a coefficient of friction that is up to half that of CoCrand will help reduce polyethylene wear3

1 Thomas J. Heyse MD, Marcella E. Elpers BS, Danyal H. Nawabi MD, Timothy M. Wright PhD, Steven B. Haas MD, ”Oxidized Zirconium versus Cobalt-Chromium in TKA: Profilometry of Retrieved Femoral Components,” Clin Orthop Relat Res. 2014 Jan;472(1):277-832 Long, M., Riester, L., and Hunter, G. no-hardness Measurements of Oxidized Zr-2.5Nb and Various Orthopaedic Materials. Trans. Soc. Biomaterials, 21, 1998, p. 528.3 Poggie RA, Wert J, Mishra A, et al (1992). Friction and wear characterization of UHMWPE in reciprocating sliding contact with Co-Cr, Ti-6Al-4V, and zirconia implant bearing surfaces. Wear and Friction of Elastomers, Denton R and Keshavan MK, Eds., West Conshohocken, PA: ASTM International.AcknowledgementsClark and Kirby Foundations, and The Trump Institute for Implant Analysis. This work made use of the Cornell Center for Materials Research Shared Facilities whichare supported through the NSF MRSEC program (DMR-1120296).

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Sa = 0.05, Sy = 1.07 Sa = 0.06, Sy = 1.14

Sa = 0.11, Sy = 1.58Sa = 0.03, Sy = 0.86

OxZr Retrieved1OxZr Pristine1

CoCr Retrieved1CoCr Pristine1

™Trademark of Smith & Nephew. Reg. US Pat. & TM Off.


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A technology from

Bearing surfaces are typically damaged in vivo. The extent of damage is variablebetween patients and rougher surfaces are associated with more wear.1 However,as the surface of OXINIUM alloy is twice as hard as CoCr alloy, it has been shownto be more resistant to the micro-abrasion which commonly takes place in jointreplacements and has been shown demonstrate better wear performance overtime vs CoCr.

Real-life Results


Performing a joint replacement is difficult enough already. This difficulty iscompounded when a patient demonstrates metal hypersensitivity to theimplant materials. Due to its unique combination of materials which has nearlyundetectable levels of nickel or chromium, OXINIUM technology provides anexcellent option for patients with metal hypersensitivity.

Biocompatibility

• 10% of the general populationis estimated to have metalallergies.1 Many may not becandidates for TKA becauseof their metal sensitivity.

• Approximately 60% of patientswith a failed or failing implantexhibit metal sensitivity.1

1 Hallab, Nadim et al. Metal Sensitivity in Patients with Orthopaedic Implants, The Journal of Bone & Joint Surgery, Vol 83-A No. 3. March 2001 p428-4362 ASTM International Standard Specification for Wrought Zirconium 2.5Niobium Alloy for Surgical Implant Applications (UNS R60901) Designation: F 2384 – 05and Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075): Designation: F 75 – 07

Prevalence of patients demonstrating metal sensitivity

Clinical studies1

Maximum chromium content

0.0% 10% 20% 30% 40%

27-30%

<0.02%

<0.02%

Cr content % by weight

Maximum nickel content

0.0% 0.2% 0.4%

<0.0035%

0.6%

0.5%

0.1%

Ni content % by weight

Metal content of implants2

• Zirconium is one of the mostbiocompatible elements.

• The Nickel and Chromiumcontent are nearly non-existentin OXINIUM™ alloy

• Surgeons now have a solutionfor patients who are nickelsensitive.

Titan

CobaltChrome

CobaltChrome

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Patienten withpoorly functioning

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A technology from


The leading cause of long term implant failure is wear. Improved polyethylene oralternative-bearing surfaces certainly could diminish the rate of failure after totalknee arthroplasty.3 VERILAST has been tested to show wear after a 30 year labsimulation that is at least 80 percent lower than conventional materials after onlythree years.‡

Wear Performance

Comparison of the mean volumetric wear of CoCr/CPE after simulating 5 Mc of use and VERILAST aftersimulating 45 Mc respectively.1

VERILAST Technology in the LEGION™Primary Knee System demonstratessuperior wear performance in 45million cycle testing.

Comparison of the mean volumetric wear of CoCr/CPEand CoCr/XLPE at 7.8Mc and 45Mc respectively.2

VERILAST Technology for Hipsdemonstrates superior wearperformance in 45 millioncycle testing.

‡ Based on in-vitro wear simulation testing, the LEGION™ Primary Knee System with VERILAST™ Technology is expected to provide wear performance sufficient for 30 years of actual use undertypical conditions. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volumeor wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysisand associated aseptic implant loosening. Particle size and morphology were not evaluated as part of the testing.

1 R. Papannagari, G. Hines, J. Sprague and M. Morrison, ?Long-term wear performance of an advanced bearing knee technology,? ISTA, Dubai, UAE, Oct 6-9, 2010.2 A. Parikh, P. Hill, V. Pawar and J. Sprague, ?Long-term simulator wear performance of an advanced bearing technology for THA,? Orthop Res Soc, San Antonio, TX, Jan 26-29, 2013, 1028.3 P. F. Sharkey, W. J. Hozack, R. H. Rothman, S. Shastri and S. M. Jacoby, “Insall Award paper. Why are total knee arthroplasties failing today?” Clin Orthop Relat Res, 2002;404:7-13.

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67% Reduction inVolumetric Wear


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VERILAST @ 45.0 Mc

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CoCr/CPE@ 7.8 Mc

CoCr/10-XLPE@ 45.0 Mc

OxZr/10-XLPE@ 45.0 Mc


A technology from


• With nearly one million OXINIUM™implants used globally, thisinnovative Technology is getting

patients back to their lives.

• Throughout the ongoing nearly 40 years of presentations, Smith & Nephew is the only orthopedic company to earn the prestigious ASM International Engineering Materials Achievement Award for its OXINIUM technology joining other recognized material innovations such as Kevlar™ fiber, synthetic diamonds and fiber optics.

Innovation and Clinical Success



A technology from

Smith & Nephew is the only orthopaedic company to ever win the prestigiousASM International Engineering Materials Achievement Award for OXINIUMTechnology. Choose the technology that has proven itself to researchersand patients worldwide.

Real-life Results


Similar to many allergies, most patients with metal sensitivitydemonstrate reactions to more than one metal. OXINIUM™ may bean effective solution for patients suffering from metal sensitivitiesdue to its unique composition.

Biocompatibility

Number of metals for which metal sensitive patientsdemonstrated reactivity (n=700)1

Five5%

>Five5%

Three18%

Two39%

One25%

Four8%



1 Forte G., et al. (2008). Metal allergens of growing significance: epidemiology, immunotoxicology,strategies for testing and prevention. Inflamm Allergy Drug Targets. 7: 145-62.

A technology from


Metal sensitivity affects an estimated 10% of the general population.2

Among patients needing revision, incidence has been reported to beapproximately 60%. OXINIUM may be an effective solution for patientssuffering from metal sensitivity.

Biocompatibility

CoCr TKA March 20081

• Three years post TKA – Pain and stiffness – Persistent rash/hair loss – ROM 5°-70°

Addressing Metal Sensitivity

Revised to OXINIUM TKA June 2011• One year post revision – Pain free – No rash – Hair returned – ROM 0-105°

Metal sensitivity after TKA should be considered when a traditional workup of a patientwith painful TKA symptoms, including arthrofibrosis and dermatitis, is negative. Theauthors found excellent results with the use of the OXINIUM™ component and proposeits use for other patients with allergic-type symptoms associated with TKA.1

1 Post, Z et al, Metal Sensitivity After TKA Presenting With Systemic Dermatitis and Hair Loss, Orthopedics, April 2013, Vol. 36, No. 4, p.525-528 2 Hallab N, Merritt K, Jacobs JJ. Metal sensitivity in patients with orthopaedic implants. J Bone Joint Surg Am. 2001; 83(3):428-436.



A technology from

VERILAST™ - Smith & Nephew. Biomech, 2005;38(2):357-365. 2. A. Parikh, M. Morrison and S. Jani,...

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