Design and Product Rationale

Product Rationale BI-MENTUM™ Dual Mobility Concept 2

Heritage and Clinical Results 3

Head to Cup Ratio 5

Range of Motion 6

Jump Distance 7

Design Rationale BI-MENTUM Acetabular Cup Features 8

BI-MENTUM Acetabular Liner Features 12

Comprehensive Cup Platform 13

BI-MENTUM™ Dual Mobility Cup Design and Product Rationale DePuy Synthes Joint Reconstruction 1

Contents

DePuy Synthes Joint Reconstruction BI-MENTUM™ Dual Mobility Cup Design and Product Rationale2

BI-MENTUM™ Dual Mobility Concept

Femoral head (ceramic or metal) – mobile polyethylene liner articulation

1

Mobile polyethylene liner – metal cup articulation

2

Femoral neck – retentive part of mobile polyethylene liner

3

DUAL MOBILITY

THIRD ARTICULATION

Product Rationale

STANDARD RANGE OF MOTION

Primary movement occurs between Femoral head – polyethylene insert articulation,

allowing the mobile polyethylene liner to sit in its natural position within the metal cup

EXTREME RANGE OF MOTION

Secondary movement occurs between polyethylene insert – metal cup articulation

when the third articulations between femoral neck and polyethylene liner is activated

TWO conceptsDesigned to reduce wear according to the

Charnley concept of low friction arthroplasty.1

Enhance stability according to the McKee-Farrar concept of large diameter femoral heads.1

Natural MOVEMENTThe dynamic mechanism of action of the 3rd bearing allows the activation of the 2nd articulation with a natural single smooth movement and enhanced Range of Motion.


Heritage and Clinical Results

BI-MENTUM Dual Mobility Cup / NOVAE equivalence table

NOVAE Dual Mobility cups

Heritage

Currently available evidence indicates that a dual mobility implant is becoming a leading treatment option to address instability for complex primary total hip replacement.2-4

To further enhance the DePuy Synthes portfolio, a strategic co-operation and supply agreement has been formed with Société d’Etude, de Recherche et de Fabrication (SERF) to exclusively launch the SERF NOVAE® SunFit TH Dual Mobility System under the brand name BI-MENTUM™ Dual Mobility System.

SERF is the original developer of the dual mobility implant with over 40 years of clinical experience.5

Over 40 yearsclinical experience5

165,000 cups provided

worldwide since 20076 (Serf NOVAE Dual Mobility Families of Cups)

1979NOVAE-1Tripod Fixation

1999NOVAE EHemispherical cup +3 mm cylindrical rim

1998NOVAELiner Optimization

2000NOVAE SunfitPressfit only fixation with Alumina and Hydroxyapatite coating

2007NOVAE TH

Circumferential Macrostructure and Titanium + Hydroxyapatite Coating

2018BI-MENTUM Dual Mobility CupIdentical Press-fit design, features and coating as NOVAE TH

BI-MENTUM Dual Mobility Cup

BI-MENTUM Press-fit Cup

BI-MENTUM Plus Cup

BI-MENTUM Revision Cup

BI-MENTUM Cemented Cup

BI-MENTUM Polyethylene Liners

BI-MENTUM Reinforcement Cage

SERF EquivalentNOVAE

SUNFIT THNOVAE

E THNOVAE

COPTOS THNOVAE STICK

NOVAE Cl E liners

NOVAE K E Cross


Heritage and Clinical ResultsClinical Results

A single-centre prospective study of 100 consecutive primary THAs using the press-fit Sunfit TH® dual mobility cup and a cementless straight stem.

93 patients (43 females, 50 males) with a mean age of 71.81 years (range: 40-94 years). 4 patients were lost to follow-up and 19 died with their implants still in place. The mean follow-up was 10.03 years.

Mean Harris Hip score significantly improved from 56 ± 15.2 pre-operatively to 93 ± 8.4 (p<0.001) and the mean Postel Merle d’Aubigné score significantly improved from 11.8 ± 2.1 pre-operatively to 17 ± 1.6 post-operatively (p<0.001).

There were no cases of aseptic loosening, dislocation or intra-prosthetic dislocation.

This study reports excellent survivorship rates of 100% at 10 years follow-up with revision for aseptic loosening considered as the endpoint.

Laurendon L, Philippot R, Boyer B, Neri T, Farizon F. Surgical Technology International. 2018 Apr; 32: 9851

Ten-Year Clinical and Radiological Outcomes of 100 Total Hip Arthroplasty Cases with a Modern Cementless Dual Mobility Cup7

Product Rationale


Head to Cup Ratio

A larger femoral head diameter increases the head to neck ratio. This can improve range of motion, jump distance and reduce the occurrence of prosthetic neck impingement to the acetabular cup. This in turn helps reduces the risk of dislocation.1

The large diameter mobile liner in the BI-MENTUM Dual Mobility System is 6 mm smaller than the outer diameter of the acetabular cup. The 6 mm is derived from the 3 mm wall thickness.

BI-MENTUM Dual Mobility System head to cup ratio compares favourably to a conventional bearing as shown below.

ALTRX® Neutral Liner36 mm Metal or Ceramic head

PINNACLE Hips Solution Primary Cups have +12 wall thickness

52 mm PINNACLE® Cup

45 mm Mobile Polyethylene Liner28 mm Metal or Ceramic head

BI-MENTUM Dual Mobility System have +6 wall thickness

51 mm BI-MENTUM Cup

*52 mm PINNACLE Hip solution used as example as this is the smallest cup size to provide a 36 mm metal or ceramic on polyethene bearing

36 mm 45 mm


Range of Motion

Although stability and “potential” range of motion increases with bearing diameter, there is little improvement in clinical range of motion for heads greater than 37 mm to 41 mm because bony impingement becomes the governing factor8

BI-MENTUM with CORAIL® AMT Collarless Stems (Range of Motion (ROM) calculated as FE and AA sweep angle)9

BI-MENTUM Cup

Flexion / Extension (FE) Abduction / Adduction (AA)

BI-MENTUM Dual Mobility System provides:• 37 mm diameter mobile liner in the smallest Pressfit cup (43 mm)• 41 mm diameter mobile liner at a size 47 mm cup• Cup size range from 41-43 mm to 69mm

(NOTE this is based on the Pressfit fixation range; a 41 mm can also be provided in the Plus fixation option)

Product Rationale

156˚

114˚


Jump Distance

Definition of jump distance: is the distance a femoral head must travel to dislocate after impingement. The greater the jump distance, the greater the stability of the hip; thus, helping to reduce the risk of dislocation.10

Jump distance is dependent on the combination of head size, depth of the cup and degree of inclination of the cup.

The chart below shows jump distance for both BI-MENTUM 51 mm Cup / 28 mm head and PINNACLE ALTRX 52 mm Cup / 36 mm head for different inclination angles.

Jump Distance for different implant types, sizes and inclination angles11

0

2

4

6

8

10

12

14

16

18

20

22

24

26

28

30

32

34

35 40 45 50 55

BI-MENTUM - 28/51 ALTRX/PINNACLE - 36/52

Inclination Angle (degrees)

Jum

p D

ista

nce

(m

m)

Targ

et c

up in

clin

atio

n 45

°

Difference in jump-distance at 45° cup inclination is 6 mm


Desgin Rationale

The BI-MENTUM Dual Mobility Construct is an acetabular cup consisting of a forged stainless steel cup and a mobile polyethylene liner to be used in combination with DePuy Synthes ceramic or metal head and DePuy Synthes stems with a polished neck.

Cementless BI-MENTUM Dual Mobility Cups are coated with plasma-sprayed titanium (150 +/- 30μm) and hydroxyapatite (70 +/-20μm). All cup variants have a polished bearing surface with a 3 mm cylindrical extension which increases jump distance compared to a hemispherical bearing.

• A macrostructure of concentric rings increases the surface area with the aim of improving primary fixation.

• The external pole of the cup is slightly flattened (-0.5 mm), with the aim of reducing stresses at the base of the acetabulum and preventing the cup from being forced out of the acetabulum, which may lead to better cup impaction and pressfit at the equator of the cup.

BI-MENTUM Acetabular CupAcetabular Cup Features

Flattened Pole

Highly polished rim

Plasma-sprayed titanium and hydroxyapatite coating

with macrostructure

3 mm cylindrical rim


All BI-MENTUM Dual Mobility System Cup variants have a polished bearing surface with a 3 mm cylindrical extension which increases jump distance (AB) compared to a hemispherical bearing.

Fixation

Dislocation Resistance

The dislocation risk decreases when the AB distance increases

NOTE: AB distance depends on head diameter, depth of the cup and the degree of inclination of the cup

A band of raised structures at the equator of the cup (ridges) in three areas: ischium, pubis and ilium contribute to the implants primary stability and aids the mechanical press-fit fixation of the device.

120°

120°

120°

Hemispherical Hemispherical +3 mm cylinrical extension

A BA B


BI-MENTUM Acetabular CupFixation

BI-MENTUM Plus and Revision Dual Mobility Cups have the same macrostructure and coating as the BI-MENTUM Pressfit Dual Mobility System. These variants allow for additional fixation through the use of cortical screws and anchoring pegs, the revision cup also has an obturator hook for additional fixation.

BI-MENTUM Plus and Revision Dual Mobility Cups are anchored in the acetabulum using the tripod principle: 1 peg in the ischium, 1 peg in the pubic bone and cortical screws in the ilium through flanges.

BI-MENTUM Revision Dual Mobility Cups also utilise an obturator hook to ensure anatomical re-centering and provides additional mechanical support.

Illiac Flange

Obturator Hook

Anchoring Pegs

Desgin Rationale


BI-MENTUM Cemented Dual Mobility Cups are grit blasted and have radial, circumferential and longitudinal grooves to aid primary anchoring and rotational stability in the cement mantle. Cemented cup can be used alone or in combination with the BI-MENTUM Reinforcement Plates.

BI-MENTUM Reinforcement Plates have a cruciform shape with an obturator hook and ischial flange designed to accommodate up to four screws.

• The plates are both sided (Left and Right) and size specific.• The plates have an outer diameter (OD) designed to fit with BI-MENTUM

cemented cups with OD 7 mm smaller than the plate e.g. a 50 mm BI-MENTUM Reinforcement Plate accomodates a 43 mm BI-MENTUM cemented cup.

• Spacers on each arm of the plate help to maintain a uniform cement mantle.

Illiac Flange

Radial circumferential and longitudinal grooves

Obturator Hook

Cement spacers


BI-MENTUM Acetabular LinerAcetabular Liner Features

The unconstrained polyethylene (PE) liners are made from conventional UHMWPE (GUR1050). When articulating within the polished stainless steel cup, a PE liner transfers reduced torque to the cup when compared with hard on hard bearings.12

Desgin Rationale

The spherical outer surface allows bearing to move freely within the cup

The liner is a hemisphere +11 mm

The liner is chamfered to delay contact of the 3rd bearing and to

increase ROM of the 1st bearing

The liner has a narrowed bore (circular hole) within which the head is secured

Chamfered Edge Inner Bore


for use with BI-MENTUM Plus and Revision

Comprehensive Cup Platform

Comprehensive Cup Platform

Bi-MENTUM PressfitØ 43-69

22 mm head PE Liner

BI-MENTUM CementedØ 43-63

28 mm head PE Liner

Bi-MENTUM RevisionØ 43-69

Bi-MENTUM PlusØ 41-69

Pegs, Screws and Hook can be used in combination with the BI-MENTUM Pressfit Ti Plasma / HA Coating to provide additional fixation

BI-MENTUM Size (OD/mm)

BI-MENTUM Pressfit

BI-MENTUM Plus

BI-MENTUM Revision

BI-MENTUM Cemented

22mm PE liner

28mm PE liner

41 * *

43 * * * * *

45 * * * * *

47 * * * * * *

49 * * * * * *

51 * * * * * *

53 * * * * * *

55 * * * * * *

57 * * * * * *

59 * * * * * *

61 * * * * * *

63 * * * * * *

65 * * * * *

67 * * * * *

69 * * * * *

Cortical ScrewsPegs

References

1. Bouchet R, Mercier N, Saragaglia D. Posterior approach and dislocation rate: A 213 total hip replacements case-control study comparing the dual mobility cup with a conventional 280-mm metal head/polyethylene prosthesis. Orthop. & Traum: Surg. & Res. (2011) 97, 2-7.

2. Combes A, Migaud H, Girard J, Duhamel A, Fessy MH. Low rate of dislocation of dual-mobility cups in primary total hip arthroplasty. Clin Orthop Relat Res. 2013 Dec;471(12):3891-900.

3. Vermersch T, Viste A, Desmarchelier R, Fessy MH. Prospective longitudinal study of one hundred patients with total hip arthroplasty using a second-generation cementless dual-mobility cup. International Orthopaedics (2015) 39:2097-2101.

4. Philippot R, Camilleri JP, Boyer B, Adam P, Farizon F. The use of a dual-articulation acetabular cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 15 years. Int Orthop. 2009;33:927–932.

5. F. Farizon, R. de Lavison, J.J. Azoulai, G. Bousquet*. Results with a cementless alumina-coated cup with dual mobility. A twelve-year follow-up study. Int. Orthop. (1998), 22, 219-224.

6. SERF Internal Data. SERF Novae worlwide implantations 2007 - 2017. Data on File.

7. Laurendon L, Philippot R, Boyer B, Neri T, Farizon F. Ten-Year Clinical and Radiological Outcomes of 100 Total Hip Arthroplasty Cases with a Modern Cementless Dual Mobility Cup. Surgical Technology International. 2018 Apr; 32: 985

8. Dual Poly Liner Mobility Optimizes Wear and Stability in THA: Opposes, Matthew C. Lyons, MBBS, FRACS; Steven J. Macdonald, MD, FRCSC, OrthoSuperSite.com. Search: 20110714-24, 2011”

9. Data on File. DePuy Synthes Internal Test report 103475467

10. Crowninshield RD, Maloney WJ, Wentz DH, et al.Biomechanics of large femoral heads: what they do and don’t do. Clin Orthop 2004; 429:102.

11. Data on File. DePuy Synthes Internal Test report 103469937

12. Brockett C, Williams S, Jin Z, Isaac G, Fisher J. Friction of total hip replacements with different bearings and loading conditions. J Biomed Mat Res B: Appl. Biomater. 2007l 81B: 508-515

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Design and Product Rationale

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