Consumer Alert: Smith & Nephew Issues a Recall on Oxinium Cementless Knee Replacements
Smith & Nephew, the international medical device conglomerate, headquartered in London, England, researches, develops, and markets medical orthopedic, endoscopic, and wound management products to medical communities throughout the world. Smith & Nephew developed cementless knee replacement implants, known as Oxinium Genesis II and Oxinium Profix II.
These Oxinium knee components worked more efficiently than the original metal cobalt chrome or titanium knee replacements of the past. The Oxinium implants reduce the amount of rubbing and resistance between the replacement components and surrounding tissue areas [i].
In the past, cobalt chrome or titanium based metals were considered the best material for knee replacements because of wear resistance. However, recent studies indicate that cobalt chrome femoral implants wear over time [ii]. When cobalt chrome or titanium is exposed to large amounts of stress from daily activity such as walking, it produces particles of matter, which produce inflammation known as osteolysis [iii].
The Oxinium knee replacement became a commonly used surgical procedure because of the increasing prevalence of knee replacement surgery; approximately 300,000 knee replacement procedures are performed in the United States annually. Approximately 3,000 patients had the Oxinium knee replacement [iv].
In August 2003, Smith & Nephew sent an alert to the US Food and Drug Administration after an Oxinium product defect was discovered [v]. Then, in September 2003, Smith & Nephew issued a recall on the design and function of the cementless knee implant in the United States. The macrotexturing surface failed to provide proper bonding to the bone, leading to increased pain and loosened knee joints. As of February 2005, approximately 26% (782 out of 2971 cases) of the Oxinium knee implants required revision surgery [v].
A number of these cementless knee implants are defective, causing increased amounts of pain, increased risks of revision surgery, infections, swelling and inflammation, more joint, tissue, and/or muscular damage, and increased rehabilitation.
Have you or a loved one had an Oxinium cementless knee replacement? Contact us.
- Smith & Nephew Product Portfolio. (2005). Orthopedics Oxinium Genesis II and Profix II Knee Systems. London, England
- Burns, Andrew. (2003). Smith & Nephew Advances Unicondylar Knee Surgery with Accuris Instrument and Oxinium Implant. London, England http://www.smith-nephew.com/news/item.jsp?id
- Cemented and Cementless Knee Replacements (2001). American Academy of Orthopedic Surgeons. Rosemont, IL
- Knee Replacement: Surgery Can Relieve Pain (October 2005); Mayo Clinic Health Information Division. Rochester, MN.
- Smith & Nephew: Risk Reports (2004 Annual Report). London, England http://www.smith-nephew.com/investors/annualreport2004/html