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Page 1: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop
Page 2: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

Today’s fastest growing segment of knee replacement patients is seeking a return to a more active lifestyle.1

Traditional knee replacement options don’t meet the need for higher functionality, improved motion or long-term

durability.2,3,4,5 Most signifi cantly, these traditional systems fall short in providing a return to a normal pattern of

motion. Lack of motion, both selection and kinematics, can mean less satisfaction for patients who are unable to

return to the demanding activities of their active lifestyle. Surgeons are left tempering patient expectations and

tolerating the limited capabilities of traditional knee replacements.

The challenge is

0 20 40 60 80 100

dancing

racquet sports

golf

carrying heavy objects

gardening

kneeling

squatting THA TKATHA

34%Post-op

42%Preop

52%Postop

36%Preop

Graph 1 2

Percent reporting no diffi cultyGraph 2 3

Sports activity

Controlsubjects

TKA

patients

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Anatomic design conforms to

patient anatomy and improves

patella tracking

Four peg divergent design

allows for superior fi xation

‘S’ shaped trochlear groove is

designed to provide optimal

patella tracking

Grit blasted undersurface

has shown excellent long

term fi xation

For orthopaedic surgeons seeking treatment solutions beyond traditional knee

replacements, JOURNEY™ PFJ has been engineered to empower patients with a

renewed right to an active lifestyle by breaking through traditional knee replacement

barriers and helping patients revive their Function, Motion and Durability through

PHYSIOLOGICAL MATCHING Technology.

The solution is

PHYSIOLOGICALMATCHING™ Technology

Page 4: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

Extra small

Small

Medium

Large

Extra small

Small

Medium

Largge

S-shaped trochlear groove

Function Conforming

• Unlike most competitors, JOURNEY™ PFJ has an

anatomically conforming implant that is tailored to a

person’s native anatomy. It is designed to conform to both

a left and right femur, whereas most other patellofemoral

replacements (PFRs) have one implant for both hands.

• JOURNEY PFJ’s anatomic shape has optimal bone

coverage, which helps to reduce stress shielding and

bone resorption. Studies have shown that JOURNEY PFJ

has stresses comparable to the physiological knee.6

Forgiving

• Patented S-shaped trochlear groove allows for more

forgiving alignment and better patellar tracking with a

much lower incidence of lateral retinaculum releases.7,10,12

• JOURNEY PFJ was the first fully instrumented PFR

on the market, allowing surgeons more options and

better intraoperative control of preparation, alignment,

and implant positioning. It is coupled with patella

instrumentation that features both a resurfacing and

resection based option for a surgeon’s preference.

• The same peg confi gurations in all sizes allow seamless

trialing and more intraoperative fl exibility.

JOURNEY PFJ

anatomic

asymmetric

Avon PFJ

non-anatomic

symmetric

Midline

Page 5: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

Satisfaction

• Despite the prevailing perception that PFRs have a very

low incidence and are uncommon, studies have shown

that approximately 1/3 of people over 60 experience

patellofemoral joint space narrowing, and 24.3% of

women and 11.0% of men with knee pain have isolated

patellofemoral compartment arthritis. Additionally,

patellofemoral joint pain is the most common problem

in the knee, affecting approximately 25% of the

population. 8,17

• While early PFRs demonstrated poor results, second

iteration designs with less constrained trochlear

grooves have been shown to have excellent clinical

results.9 Beitzel et al saw exceptional results with the

JOURNEY™ PFJ through statistically improved PFR

post-operative clinical scores at 2-year follow-up.13

• JOURNEY PFJ was predicated from the previous

Richards II PFJ, which achieved 98% survivorship with

mean follow up of 17 years.9

• Studies have shown that many arthritic patients are

good candidates for PFR and that clinical outcomes

tend to be excellent for these patients in the long term

as a result of ligament and tissue preservation, more

normal gait and kinematics, quicker recovery, increased

satisfaction scores, easier and cheaper revisions, and

lower healthcare costs.18,19,20,21,22

Incidence of compartmental arthritis In men with knee pain

Incidence of compartmental arthritis In women with knee pain

p

Medial PFJ

Lateral

p

Medial PFJ

Lateral

21.2% 6.8% 11.0%

1.7%

1.7%.8%

0%

12.3% 6.3% 24.3%

2.7%

.3%

1.0%

2.7%

17

17

Page 6: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

S-shaped trochlear groove

Midline

Motion Patellofemoral kinematics

• The patented s-shaped groove of the JOURNEY™YY PFJ has ™

shown great clinical history in both the GENESIS™ II and ™

LEGION™ primary systems.™ 7,10,12

• The deepened and lateralized trochlear groove of the

JOURNEY PFJ drives normal superior patella tracking and

has been clinically shown to have lower lateral release

rates compared to other designs.7,10,12 Lateral retinaculum

release in patellofemoral joint instability has been shown

to promote reoccurrence of instability, indicating

PFJ releases should be avoided whenever possible.11

• Studies have shown that PFR and combined

unicompartmental and patellofemoral joint procedures

produce more normal kinematics and gait patterns when

compared to TKR.18,21

• PFRs allow patients to maintain normal kinematics and

gait patterns in relation to the normal physiological

conditions, allowing patients to have better satisfaction

and feel more normal.18,19,20,21,22

Page 7: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

Fixation

• JOURNEY™YY PFJ utilizes four convergent pegs that have ™

been shown to provide excellent long term fi xation.13,14

• Grit blasted underside with cement grooves have been

designed to promote superior cement adhesion.13,14

• JOURNEY PFJ has been found to have normal

physiological loading patterns compared to the normal

knee in fl exion, reducing the chance of adverse effects

from stress shielding and bone resorption, such as

loosening.14

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Wear

• OXINIUM™ Oxidized Zirconium is an advanced bearing

material that combines the strength of metal with the

wear resistance of ceramics.28

• OXINIUM Technology is 4,900 times more resistant to

abrasion than CoCr.23

• OXINIUM Technology is more than twice as hard as

CoCr.24

• OXINIUM Technology has a coeffi cient of friction that is

up to half that of CoCr.25

• Oxidized Zirconium provides the perfect combination

of toughness and excellent wear properties for younger

and/or active PFR patients that will require implants to

last many years. OXINIUM™ alloy has been shown to have

lower wear rates when compared to the same devices with

CoCr.31,32

Metal sensitivity

We understand that no measurable nickel content is

of immeasurable benefi t to nickel-sensitive patients.

• OXINIUM Oxidized Zirconium, exclusively from

Smith & Nephew, addresses the needs of nickel-

sensitive patients by having <0.0035% nickel content,

compared to 0.5% in cobalt chrome and 0.1%

in titanium.26

• Zirconium is a nearly inert material that has not reported to

induce immune reactions.26

0.0 100.0-100.0

-100.0

200.0-200.0

-200.0

300.0-300.0

-300.0

400.0-400.0

-0.8

-0.6

-0.4

0.0

0.2

-0.2

0.0 100.0-100.0

-100.0

200.0-200.0

-200.0

300.0-300.0

-300.0

400.0-400.0

100.0

200.0

00.0

-100.0

-200.0

400.0

500.0

300.0

0.0 100.0-100.0 200.0-200.0

-200..0

300.0-300.0

-300.0

400.0-400.0

-0.8

-0.6

-0.4

0.0

0.2

-0.2

0.0 100.0-100.0 200.0-200.0

-2

300.0-300.0

-300.0

400.0-400.0

100.0

200.0

00.0

-100.0

-200.0

400.0

500.0

300.0

10010-100-100-100-1001000000001011001-10000111111-10000111000100-11100-1000001-111000-100000001-1000000100000000--1000000000-100-100- 000-1000000101011010000010001000001001000000000 00000000000000000000000000000.000..00.0.0.00000.000

200..0

-100.0-

Sa = 0.11, Sy = 1.58

Retrieved

3D surface profi les of retrieved Oxidized Zirconium and Cobalt-Chromium femoral components

Durability

Co

Cr

OxZ

r

Page 9: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

Flexibility

• JOURNEY™YY PFJ is fully integrated and interchangeable ™

with all JOURNEY Active Knee solutions. It can be used

effectively in combination with JOURNEY UNI in cases

that require both compartments to be replaced. Studies

have shown that this bi-compartmental replacement can

be very effective in treating patients, by preserving soft

tissue and achieving normal gate patterns compared to a

TKA. Approximately 7% of patients could be candidates

for this procedure.15,16,17,18,21

• Unlike many other PFJ competitor implants, JOURNEY PFJ

has a seamless transition to JOURNEY II CR, JOURNEY

II BCS, or LEGION™ Primary TKR as a bailout or revision™

option.

• Unlike most TKA systems, JOURNEY PFJ and JOURNEY

UNI are both minimally invasive procedures that preserve

native ligaments and tissue, and as a result have much

easier and less costly revisions compared to many other

systems.

Radiation dose (Mrad)

Tumbled CoCr

Pristine CoCr

Tumbled OxZr

Pristine OxZr

JOURNEY PFJ

JOURNEY UNI

JOURNEY II BCS JOURNEY II CR

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Patented the usage of

Oxidized Zirconium with

orthopaedic medical devices

The introduction of the GENESIS TKS was a significant step in the evolution of the

modern knee designs. It was the first system to “Address the Unexpected.” With a

single set of instruments and implants, virtually any interoperative situation could be

handled. This technological advancement greatly simplified the process of TKA.

Designers: Dr. Ramon Gustilo, Dr. Jim Rand, Dr. Richard Laskin, Dr. James Howe,

and Dr. Todd Swanson.

Launched as one of the first asymmetric femoral

component designs, opening up the opportunity

for less traditional knee designs. Over 1 million

GENESIS II knees have been implanted globally.

The first OXINIUM™ alloy total knee implantation.

Over the past 15 + years over 600k OXINIUM Alloy

hips and knees have been implanted worldwide

Richards Manufacturing collaborate with Dr.

Leonard Marmor to commercially produce

the first unicondylar knee on the market.

1988

1976

GENESIS™ Total Knee System

1991 OXINIUM Oxidized

Zirconium Patented

GENESIS UNI launched in collaboration

with Professor Cartier and Dr. James

Andrews has demonstrated to be one

of the most clinically successful

unicondylar knees on the market

(94.5% at 10 years).41

1995 GENESIS UNI

The JOURNEY PFJ combines the clinically proven

performance of its trochlear groove with powerful

precision-the first completely instrumented

JOURNEY PFJ system for greater reproducibility and

ease of use. Designers: E. Lyle Cain, Jr, MD,

Jeffrey R. Dugas, MD, Dr. John Neuman, FRCS,

William B. Smith, MD,

Engineering Materials Achievement Awarded

to Smith & Nephew for use of OXINIUM Oxidized

Zirconium. Established in 1969, this award

recognizes an outstanding achievement

in materials or materials systems relating

to the application of knowledge of materials

to an engineering structure or to the design

and manufacture of a product. Smith & Nephew

is the only orthopaedics company to ever win this

award. Past recipients include: GE, Dupont,

IBM, Texas Instruments, Dow Corning,

Northrup Grumman

1997 GENESIS II Total Knee System

Using advanced biomechanical

modeling technologies; the

JOURNEY BCS was the first TKA

to accurately replicate the normal

kinematic patterns of the healthy

knee joint. Over 60,000 JOURNEY

BCS knees have been implanted

around the world. ‘Most

Significant New Product at AAOS’

(2006) Designers: Prof. Johan

Bellemans, Dr. Jonathan Garino,

Dr. Steven Haas, Dr. Michael Ries,

and Prof. Jan Victor.

2005 JOURNEY BCS

The LEGION Revision Knee System was designed to strike a perfect balance

by providing simple, efficient instruments specific to revision and a broad

range of implant options to address even the most demanding surgeries.

Combined with Oxidized Zirconium, LEGION Revision helps surgeons give

their patients the potential for better outcomes with lower wear.

2005 LEGION™ Revision Knee (RK)

2005

2006 JOURNEY PFJ

From the company that brought the first commercial PFJ to market…

Following on a rich history of partial knee arthroplasty

and success of the JOURNEY™ BCS design – which

showed recovery of normal patterns of motion and high

gains in flexion 6-13, 21, 27-28 – Smith & Nephew has created

a seamless, next generation family of partial and

primary knee systems designed to help restore

patients' level of function, motion and durability.

1972 Richards Manufacturing Company Marmor Uni

Richard’s Manufacturing developed the first

commercially available patellofemoral joint

replacement on the market.

Richards Manufacturing Company PFJ

1970 1980 1990 2000

Page 11: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

VERILAST Technology, a one-of-a-kind advanced

bearing couple of OXINIUM™ Oxidized Zirconium with

highly-crosslinked polyethylene formulation designed

specifically for knees.

JOURNEY UNI knee treats isolated compartmental

disease with anatomic components coupled with

simple, intuitive instrumentation for a streamlined,

reproducible technique. Designers: Dr. William

Bugbee, Dr. Donald Polakoff, Dr. Jonathan Young,

Dr. Stuart Smith, Dr. Douglas Naudie, Dr. Paul Saenger,

Dr. and Jerome Rubini

In 2009 Smith & Nephew globally launched the foundation of its

patient specific solutions, VISIONAIRE Patient Matched Cutting

blocks. Smith & Nephew was the first company to launch patient

matched technology developed and manufactured completely

in house.

The next generation of normal function,

motion and durability. More normal

kinematics and function-strength, stability

and higher flexion achieved through the

unique features of the JOURNEY II BCS

system; normal shapes, normal position

and normal motion. Designers:

Prof. Johan Bellemans, Dr. Jonathan Garino,

Dr. Steven Haas, Dr. Michael Ries, and

Prof. Jan Victor, Dr. Mark Snyder and

Dr. Fred Cushner.

2012 JOURNEY II BCS

Revolutionary approach to addressing medial femoral and

patella-femoral disease in monolithic component. The lessons

gained from experiences have allowed advanced kinematic

evaluations. Designers: Dr. Lindsey Rolston and Dr. Gerard Engh.

2008 JOURNEY UNI

2007 JOURNEY™ DEUCE

Smith & Nephew purchased the Swiss company PLUS

Orthopedics. This added the PLUS SOLUTION knee family to

the portfolio: TC-PLUS™ PRIMARY, TC-PLUS REVISION, and

RT-PLUS™ REVISION. The PLUS Knee family is developed and

manufactured in Switzerland and offers a seamless system;

from Primary – Complex Primary – Revision – Hinge Knee.

2007 PLUS Orthopedics

2008 Launched VERILAST™ Technology

2009 VISIONAIRE™ Patient Matched Instrumentation

LEGION Hinged Knee is launched as an extension

of the clinically successful LEGION Total Knee System.

Its kinematic and bone sparing design not only alleviates

patients’ symptoms, but also restores an almost natural knee

function. Coupled with its ease of use by allowing surgeons

to seamlessly transition intraoperatively from a constrained

revision implant to a hinged assembly, it makes knee

salvage, knee rescue.

2012 LEGION™ Hinge (HK)

Smith & Nephew announces the acquisition of

LifeModeler, Inc. (LMI), the leading provider of

biomechanical human body simulation tools and services.

LMI’s groundbreaking software shortens the time taken

to develop new products by enabling the evaluation of

innovations in a virtual model of the human body. New

orthopaedic products can be tested and validated faster,

more extensively, and more cost effectively prior to the

production

of a physical prototype.

2012 Acquisition of LifeMod

Designed to be the first kinematically

correct cruciate retaining TKA on the

market designed in collaboration with

Professor Johan Bellemans, Dr. David

Drucker, Dr. Alois Franz, Dr. Murali Jasty,

Dr. Gerald Jerry, Dr. Michael Ries, Mr. Neil

Thomas, Dr. Alfred Tria, Professor Jan

Victor and Dr. Ate Wymenga

In 2013 Smith & Nephew launched

Patient Specific Logistics with Universal

Instrument Trays. This industry leading

initiative allows for Smith & nephew to

provide “just in time logistics” where

instruments specific to each patient

including size and hand are provided for

each surgery helping to reduce hospital

costs and improve operating room

efficiency.

2013 VISIONAIRE

Technology and Patient

Specific Logistics

2014 JOURNEY II CR

2010

Page 12: The challenge is - Smith & Nephew · The challenge is 020 40 60 80 100 dancing racquet sports golf carrying heavy objects gardening kneeling squatting THA TKATHA 34% Post-op 42% Preop

References

1. US Department of Health and Human Services Agency (HHSA) for Healthcare Research and Quality (AHRQ) Knee Replacements Up Dramatically Among Adults 45 to 64 Years Old. AHRQ

News and Numbers, November 3, 2011. Agency for Healthcare Research and Quality, Rockville, MD.

2. Phil Noble et al; Does total knee replacement restore normal knee function? 2005; CORR. (431): 157-65.

3. Huch K, Müller KA, Stürmer T, Brenner H, Puhl W, Günther KP. Sports activities 5 years after total knee or hip arthroplasty: the Ulm Osteoarthritis Study. Ann Rheum Dis. 2005 Dec; 64

12):1715-20.

4. Comparing patient outcomes after THA and TKA: is there a difference? Bourne RB, Chesworth B, Davis A, Mahomed N, Charron K. Clin Orthop Relat Res. 2010 Feb; 468(2):542-6. Epub

2009 Sep 4.

5. Functional comparison of posterior cruciate-retained versus cruciate-sacrifi ced total knee arthroplasty. Dorr LD, Ochsner JL, Gronley J, Perry J. Clin Orthop Relat Res. 1988 Nov; (236):36-43.

6. van Jonbergen et al.: Differences in the stress distribution in the distal femur between patellofemoral joint replacement and total knee replacement: a fi nite element study. Journal of Orthopaedic

Surgery and Research 2012 7:28.

7. Kaper, Bertrand, Michael Woolfrey, and Robert Bourne. “The Effect of Built-in External Femoral Rotation on Patellofemoral Tracking in the Genesis II Total Knee Arthroplasty.” The Journal of

Arthroplasty 15.8 (2000): n. pag. Print

8. Davies, A. P., A. S. Vince, L. Shepstone, S. T. Donell, and M. M. Glasgow. “The Radiologic Prevalence of Patellofemoral Osteoarthritis.” Clinical Orthopaedics and Related Research 402 (2002):

206-12. Print

9. Kooijman, H.J., P.P.M. Driessen, and J.R. Van Horn. “Long-term Results of Patellofemoral.” The Journal of Bone and Joint Surgery (2003): n. pag. Print.

10. Laskin RS, Davis J. Total knee replacement using the Genesis II prosthesis: a 5-year follow up study of the fi rst 100 consecutive cases. Knee. 2005 Jun;12(3):163–167.

11. Briard, J., and D. Hungerford. “Patellofemoral Instability in Total Knee Arthroplasty.” The Journal of Arthroplasty 4 (1989): S87-97. Print.

12. Bourne RB, McCalden RW, MacDonald SJ, Mokete L, Guerin J. Infl uence of patient factors on TKA outcomes at 5 to 11 years followup. Clin Orthop Relat Res. 2007 Nov;464:27–31.

13. Beitzel, Knut, Philip Schottle, Matthias Cotic, Vyas Dharmesh, and Andreas Imhoff. “Prospective Clinical and Radiological Two-year Results after Patellofemoral Arthroplasty Using an Implant with

an Asymmetric Trochlea Design.” Knee Surgery Sports Tramatol Arthroscopy (2012): n. pag. Print.

14. Van Jonbergen, Hans-Peter W., Bernardo Innocenti, Gian L. Gervasi, Luca Labey, and Nico Verdonschot. “Differences in the Stress Distribution in the Distalfemur between Patellofemoral Joint

Replacement and Total Knee Replacement: A Finite Element Study.” Journal of Orthopaedic Surgery and Research 7.28 (2012): n. pag. Web

15. Abdulkarim, Ali, Turlough O’Donnel, and Michale Neil. “The Infl uence of Patellofemoral Degenerative Changes on the Outcome of Unicompartmental Knee Replacement (UKA).” Internation

Journal of Joint Surgery 11.8 (2013): 661. Print

16. Heyse, Thomas Jan, Ahmed Khefacha, and Philippe Cartier. “UKA in Combination with PFR at Average 12-year Follow-up.” Archives of Orthopaedic and Trauma Surgery 130.10 (2010): 1227-230.

Print.

17. McAlindon, T. E., S. Snow, C. Cooper, and P. A. Dieppe. “Radiographic Patterns of Osteoarthritis of the Knee Joint in the Community: The Importance of the Patellofemoral Joint.” Annals of the

Rheumatic Diseases 51.7 (1992): 844-49. Print.

18. Komistek RD, Mahfouz MR, Bertin KC, Rosenberg A, Kennedy W (2008) In vivo determination of total knee arthroplasty kinematics: a multicenter analysis of an asymmetrical posterior cruciate

retaining total knee arthroplasty. J Arthroplasty 23(1):41–50

19. Wilkenson, M.P.R, and F.S. Haddad. “Patellofemoral Joint Replacement.” Bone and Joint (2010): n. page. Print

20. Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM (2002) Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res (404):7–13

21. Wang, He, Eric Dugan, Jeff Frame, and Lindsey Rolston. “Gait Analysis after Bi-compartmental Knee Replacement.” Clinical Biomechanics 24.9 (2009): 751-54. Print.

22. Rolston, L., J. Bresch, G. Engh, A. Franz, S. Kreuzer, M. Nadaud, L. Ouri, and D. Wood. “Bicompartmental Knee Arthroplasty: A Bone-sparing, Ligament-sparing, and Minimally Invasive

Alternative for Active Patients.” Orthopedics 3rd ser. 30.70 (2007): n. pag. Print.

23. Hunter, G., and Long, M. Abrasive Wear of Oxidized Zr-2.5 Nb, CoCrMo, and Ti-6AI-4V Against Bone Cement. 6th World Biometerials Cong. Trans. Society of Biomaterials, Minneapolis, MN.

2000, p. 835.

24. 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.

25.Poggie RA, Wert J, Mishra A, et al (1992) Friction and wear characterization of UHMPWE 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.

26. Nasser, S.: Biology og Foreign Bodies: Tolerance, Osteolysis and Allergy in Total Knee Arthroplasty, Edited by J. Bellemans, M.D. Ries and J. Victor, Springer-Verlag, Heidelberg, 2005.

27. Parikh, G. Hines and V. Good, “ Knee simulator wear testing of smooth and roughened cobalt-chrome GENESIS™ II femoral components articulating against 7.5 Mrad XLPE and conventional

UHMWPE”, OR report: OR-06-07A, Smith & Nephew, Inc., June 2006.

28. Morrison, M L;1Jani, Parikh, A. “Development of an Advanced Bearing Couple for Total Knee Arthroplasty”, OR report: 1125, Smith & Nephew, Inc., ORS 2011.

Smith & Nephew, Inc.7135 Goodlett Farms Parkway

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01414 V1 03/14