What Is the History of the Oxinium Knee Replacement Device?


Quick Answer

Smith & Nephew developed Oxinium knee replacement devices in June 2003 using a thermodynamic process that transforms an oxidized zirconium metal into a smooth ceramic surface. The smoother linings create greater comfort with less wear and debris. Doctors implanted several thousand devices before the company initiated a product recall of its Genesis II and Proform II Oxinium devices near the end of 2003.

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Full Answer

The recalled devices failed to bond properly and led to increased risks of infections and other complications requiring revision surgery. Smith & Nephew stated at the time that a 1 percent revision surgery rate was expected but higher than the company desired. The need for revision surgeries gradually increased to 107 in 2004, and to 756, or 26 percent, by 2005.

Despite this setback, the Oxinium devices continued to gain popularity and regulatory approval. In 2005, the U.S. Food and Drug Administration granted approval for Smith & Nephew’s Oxinium hip replacement device. Shortly afterward, Japan granted full reimbursement status for both Oxinium knee and hip replacement devices, making Smith & Nephew the first company to ever gain that distinction for a medical device replacement company.

More recently, the company’s focus focuses on Oxinium replacement devices combined with Verilast technology to create a polyethylene tibial insert with an advanced total knee arthroplasty bearing. This technology leads to greater wear and performance to meet the higher expectations of younger users. The latest tests indicate an 81 percent reduction in wear and a life span of up to 30 years, which is twice the industry standard, as of 2016.

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