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Based in the U.K., Smith & Nephew is a multinational corporation that develops medical equipment, including joint devices for hips, knees and shoulders. The company has created and marketed a variety of hip replacement and resurfacing products, some of which have been the subjects of or lawsuits around the globe.
Smith & Nephew Hip Surgical Techniques
As part of its hip resurfacing and hip replacement offerings, Smith & Nephew produces the Birmingham Hip Resurfacing System and Oxinium hip replacement. In the company’s literature about hip replacement techniques, Smith & Nephew promotes computer-assisted surgery, a direct anterior approach and minimally invasive surgery. According to the company, these types of minimally invasive techniques may help patients recover faster compared to traditional hip replacement surgery.1
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Oxinium Femoral Heads
Oxinium Oxide Zirconium is a patented metal alloy developed by Smith & Nephew as an alternative to other metal-on-metal hip and knee replacement devices. According to descriptions, Oxinium femoral heads are produced using a proprietary oxidization process that creates a ceramic surface while retaining an underlying metal structure. Cross-linked polyethylene (XLPE) liners are typically used with the Oxinium femoral heads. The company has claimed that the Oxinium construction process reduces the number of XLPE particles created under various conditions when compared with cobalt-chrome (CoCr) alloy devices. 2
Smith & Nephew also claims that Oxinium is harder, lighter and more durable than other hip implant types, such as CoCr. 3
However, a randomized controlled trial by Morison et al showed “no significant reduction in wear rate by using Oxinium in place of CoCr femoral heads at early follow-up.” 4
An earlier controlled randomized study of total knee arthroplasty showed “no significant differences” in patient preference between Oxinium and CoCr replacements at various points up to five years after operation. 5
As part of a settlement reached in 2012, Smith & Nephew agreed to pay $16.8 million in fines and $5.4 million in disgorgement and prejudgment interest.
Smith & Nephew Recalls and Litigation
In 2007, the U.S. Securities and Exchange Commission (SEC) began investigating Smith & Nephew for allegedly paying doctors employed by the Greek government to use the company’s equipment instead of competitors’ products. 6 As part of a settlement reached in 2012, Smith & Nephew agreed to pay $16.8 million in fines and $5.4 million in disgorgement and prejudgment interest. The company also entered into a deferred prosecution agreement with the Department of Justice as part of the settlement. 7
In June 2012, Smith & Nephew voluntarily recalled the metal liners for its R3 acetabular system, a component of hip replacement devices, after discovering that 1.6% of patients needed revision surgery each year, which exceeds the 1% guideline set by Britain’s National Institute for Health and Clinical Excellence. 8 The recall was global. In the U.S., the FDA had approved R3 metal liners only for use with the Birmingham Hip Resurfacing System. 9
In late 2012, Jana Goldin filed a product liability lawsuit against Smith & Nephew in the District of Southern New York of the U.S. District Court. As part of the complaint, Goldin claimed that she had suffered instability consistent with anterior dislocation and excruciating pain that required emergency care. Smith & Nephew filed multiple motions to dismiss the suit, and in April 2013, Judge J. Paul Oetken issued an order dismissing the case per the company’s motions. 10
- Smith & Nephew. Hip Surgery Technology. Accessed July 14, 2014.
- U.S. Food and Drug Administration. Summary of Safety and Effectiveness, Smith & Nephew, Inc. (July 25, 2003). Accessed July 14, 2014.
- Smith & Nephew. Oxinium Hips and Knees. Accessed July 14, 2014.
- Morison, Zachara A. et al. A Randomized Controlled Trial Comparing Oxinium and Cobalt-Chrome on Standard and Cross-Linked Polyethylene. (May 24, 2014) Accessed July 14, 2014.
- Hui, Catherine et al. Five-Year Comparison of Oxidized Zirconium and Cobalt-Chromium Femoral Components in Total Knee Arthroplasty. (April 6, 2011). Accessed July 14, 2014.
- Tadena, Nathalie. Medical Firm Settles Foreign Bribery Case. (Feb. 7, 2012) Accessed July 14, 2014.
- U.S. Securities & Exchange Commission. SEC Charges Smith & Nephew PLC with Foreign Bribery. (Feb. 6, 2012) Accessed July 14, 2014.
- Reuters. Smith & Nephew pulls metal-on-metal hip component. (June 1, 2012). Accessed July 14, 2014.
- U.S. Food and Drug Administration. Recalls Specific to Metal-on-Metal Hip Implants. (Updated July 2, 2014). Accessed July 14, 2014.
- Goldin v. Smith & Nephew, Inc. Memorandum and Order. (April 24, 2013). Accessed July 14, 2014.