The document discusses VERILAST technology for the LEGION primary knee system. It states that: - Based on in-vitro wear simulation testing, the LEGION system using VERILAST technology is expected to provide sufficient wear performance for 30 years of use. - The simulation results have not been proven to quantitatively predict clinical wear performance. - A reduction in wear volume or rate alone may not result in improved outcomes, as particle size and morphology are also important factors. Particle size and morphology were not evaluated in the testing.

1. VERILAST™ Technology
with LEGION™ Primary Knee System
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 under typical 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 volume or 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 osteolysis and associated aseptic implant loosening. Particle size and
morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.

2. Reasons for Revision
Peter F. Sharkey, MD; William J. Hozack, MD;
Richard H Rothman, MD, PhD; Shani Shastri,
MD; and Sidney M. Jacoby, BA
Sha rkey et al, Why Are Total Knee Arthroplasties Failing Today? CORR; Number 404, pp. 7–13 2002

3. Reasons for Revision
Sha rkey et al, Why Are Total Knee Arthroplasties Failing Today? CORR; Number 404, pp. 7–13 2002
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

4. Improving wear
UHMWPE Wear rate and Radiation
Poggie et al., ASTM STP 1145 Asano et al. Dose Effects of Cross-Linking Polyethylene for Total
Knee Arthroplasty on W ea r Perform ance and Mechanical Properties
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged. J Biomed Mater Res Part B: Appl Biomater 83B: 615–622, 2007

5. VERILAST™ Technology in the LEGION™ Primary Knee System was
tested for 30 years of simulated wear performance
160
p<0.01
120.42
140
Average volumetric wear (mm3)
Average volumetric wear (mm3)
120
100
98%
80
60
40
20 2.67
0
CoCr/CPE VERILAST
Simulation of 3 years
Comparison of the mean volumetric wear of the CoCr/CPE and VERILAST couples after simulating 3 years of use.
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 under typical 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 volume or 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 osteolysis and associated aseptic implant loosening. Particle size and
morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew. Certain marks Reg. US Pat. & TM Ofc.

6. VERILAST™ Technology in the LEGION™ Primary Knee System was
tested for 30 years of simulated wear performance
160
p<0.01
120.42
140
Average volumetric wear (mm3)
120
100
81%
80
60
22.78
40
20
0
CoCr/CPE VERILAST
3 years Simulation 30 years Simulation
Comparison of the mean volumetric wear of the CoCr/CPE after simulating 3 years of use and VERILAST after simulating 30 years of use.
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 under typical 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 volume or 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 osteolysis and associated aseptic implant loosening. Particle size and
morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.

7. VERILAST™ Technology in the LEGION™ Primary Knee System was
tested for 30 years of simulated wear performance
35
Mean volumetric wear XLPE insets (mm3)
30
25
20
15
10
5
0
3 6 9 12 15.5 19 22.5 26 30
-5
Duration Simulation (years)
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 under typical 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 volume or 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 osteolysis and associated aseptic implant loosening. Particle size and
morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.

8. VERILAST™ Technology in the LEGION™ Primary Knee System was
tested for 30 years of simulated wear performance
8.0
Oxide Thickness (!m)
7.0
6.0
5.0
4.0
3.0
0 3 6 9 12 15.5 19 22.5 26 30
Duration Simulation (years)
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 under typical 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 volume or 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 osteolysis and associated aseptic implant loosening. Particle size and
morphology were not evaluated as part of the testing. ™Trademark of Smith & Nephew.

9. VERILAST™ Technology demonstrates lower wear rates than
other XLPE formulations using similar test conditions
Conventional Material XLPE Material
Technologies Technologies
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,” http:/ /www.biomet.com/orthopedics/getFile.cfm?id=2657&rt=inline
7. 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.
™Trademark of Smith & Nephew. All Trademarks acknowledged.

10. VERILAST! Technology
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

11. Concept
Two major bearings components in TKA
• Hard metallic femoral component
• Soft polyethylene tibial component
Need a system-wide solution
VERILAST™ Bearing Technology
• Provides lowest wear combination
• OXINIUM™ femoral component
– Provides lower wear than CoCr
– Maintains low wear of XLPE
• XLPE tibial insert
– Provides higher performance than CPE
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

12. Hard bearings–OXINIUM™ Oxidized Zirconium
• History
• Properties
• Performance
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13. The history – OXINIUM™ Oxidized Zirconium
• Award Winning Technology
– ASM International
• First Implant in 1997
• > 300,000 implants
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

14. OXINIUM™ material properties
• Surface transformed ceramic
– Not a coating
• Toughness of metal and wear resistance of Air
ceramic Oxygen 500oC
Diffusion
• More wettable than CoCr
Original Surface
– Less friction than CoCr
Oxygen Enriched Metal
– Reduces wear of poly Ceramic Oxide
• Surface 2x harder than CoCr alloy Oxygen Enriched Metal
– More scratch resistant
• Nickel content less than 35 ppm Metal Substrate
– For metal-sensitive patients
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

15. Metal sensitivity
• 56 yo homemaker
– Cannot wear jewelry
• 3 yr post CoCr TKA
– Pain, stiffness
– Persistent rash
• Revised to alumina
– Rash resolved
• Contra-lateral TKA
– OXINIUM™ material used
– No sensitivity issues
Nasser et al., AAOS, S an Diego, CA, 2007, 437
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

16. Hardness – Surface of OXINIUM™ material
is 2X that of CoCr
*Long et al., SFB 1998
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17. Abrasion resistance
4900 times less volumetric wear in bone cement abrasion
test compared to CoCr
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Hunter and Long, WBC 2000

18. Microabrasive performance
CoCr vs. OXINIUM™ Material Retrieved at 30 months
CoCr OXINIUM™ Alloy
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

19. Strength and toughness
• Behaves like metal
• Supports 1000 lbf fatigue load for
10 Mc
– Similar to CoCr
• Condyle bent at 4500 lbf
– No fracture
– No oxide delamination
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

20. Coefficient of friction
• Lower coefficient of friction against
polyethylene and against cartilage
• Lower coefficient of friction means
less adhesive wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged. Poggie et al., ASTM STP 1145

21. OXINIUM™ alloy on CPE wear performance
• OXINIUM alloy provides improved wear
performance
– Under pristine conditions
– Due to lower friction of ceramic
surface
50%
• OXINIUM material maintains improved
wear performance
– Under microabrasive conditions
– Scratch resistance due to improved
hardness
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

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

23. Soft bearing
• Hip
– More conforming
– Lower contact stresses
– Primarily sliding motion
• Knee
– Less Conforming
– Higher contact stresses
– Complex sliding and rolling motions
• Requires different crosslink formulations
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

24. TKA Crosslinked PE Market
GUR Dose Thermal Free
Material Resin (Mrad) Treatment Sterilization Radicals? Oxidation?
Smith & Nephew
1020 7.5 Re-melt EtO No No
XLPE
DePuy XLK 1020 5 Re-melt Gas Plasma No No
Zimmer Prolong 1050 6.5 Re-melt Gas Plasma No No
Biomet Sub-melt +
1020 10+3 Gamma-Inert Yes No
E-Poly / E1 Vit E Diffusion
Stryker X3 1020 9 = 3×3 Sub-melt Gas Plasma Yes Yes
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

25. The right amount?
“Although a certain amount of cross-linking
would be effective for clinical application of
PE tibial inserts, an optimal radiation dose
should be much smaller than that used in
current XLPE in total hip arthroplasty.”1
Asano et al. Dose Effects of Cross-Linking Polyethylene for Total Knee Arthroplasty on W ea r Perform ance and Mechanical Properties J Biomed
Mater Res of SmithB:Nephew. Reg. US Pat. & TM Off. All615–622, 2007
Part & Appl Biomater 83B: Trademarks acknowledged.
™Trademark

26. The right amount
Asano et al. Dose Effects of Cross-Linking Polyethylene for Total Knee Arthroplasty on W ea r Perform ance and Mechanical Properties J Biomed
Mater Res Part B: Appl Biomater 83B: 615–622, 2007
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

27. Crosslinking and wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

28. Knee simulator wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

29. Knee simulator wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

30. Microabrasive performance
CoCr vs. OXINIUM™ Alloy
CoCr OXINIUM
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

31. Knee simulator wear
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

32. TKA Crosslinked PE market
GUR Dose Thermal Free
Material Resin (Mrad) Treatment Sterilization Radicals? Oxidation?
Smith & Nephew
1020 7.5 Re-melt EtO No No
XLPE
DePuy XLK 1020 5 Re-melt Gas Plasma No No
Zimmer Prolong 1050 6.5 Re-melt Gas Plasma No No
Biomet Sub-melt +
1020 10+3 Gamma-Inert Yes No
E-Poly / E1 Vit E Diffusion
Stryker X3 1020 9 = 3×3 Sub-melt Gas Plasma Yes Yes
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

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

34. Free radical concentration
100000
1. Wang et al, J Appl Phys, 2006, 39, 3213-3219
2. Muratoglu et al, Clin Orth Rel Res, 2003, 417, 253-262
8900
10000
FRC (Trillion Free Radicals/g)
2800
1200
1000
100
Not Not
Detectable Detectable
10
S&N CPE S&N XLPE StrykerX3™ Stryker Gamma-Air
Crossfire™
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.

35. VERILAST™ Technology demonstrates lower wear rates than
other XLPE formulations using similar test conditions
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,” http:/ /www.biomet.com/orthopedics/getFile.cfm?id=2657&rt=inline
7. 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.
™Trademark of Smith & Nephew. All Trademarks acknowledged.

36. Summary
• VERILAST™ Bearing Technology
– Provides industry-leading wear performance
• OXINIUM™ Oxidized Zirconium femoral components
– Surface transformed ceramic
– ½ frictional forces of CoCr
– 2x hardness of CoCr
• XLPE tibial inserts
– 7.5 Mrad melt annealed
– Undetectable free radical concentration
– Oxidation resistant
– Delamination resistant
™Trademark of Smith & Nephew. Reg. US Pat. & TM Off. All Trademarks acknowledged.