Knee Replacement Recall

On September 17, 2003, Smith & Nephew PLC announced the voluntary recall of the cementless versions of its Oxinium Genesis II and Profix II knee systems. Oxinium, or oxidized zirconium, is a new material the British medical device company is using to produce longer-lasting replacement joints.

According to a Smith & Nephew spokesman, about 30 of the 3,000 patients fitted with cementless versions of its Oxinium Genesis II and Profix II implants in the U.S. have needed to have the procedure revised after the implants became loose; however, many other patients may also need to be checked to make sure the knee implant is not defective.

The company alerted the Food and Drug Administration (FDA) after the problem first drew attention in August 2003. It then decided to withdraw the products voluntarily for reasons of patient safety while it carried out a valuation to determine the cause of the problem.

The Smith & Nephew knee replacements failed to properly bond. Due to a lack of bone adhesion to the implant, there have been many cases of implants loosening and cases of implants never bonding to the underlying bone. As a result, some patients require painful and expensive revision surgery, which increases the risk of infection and further joint and muscular damage that could cause a more painful rehab.



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