In September 2003, London based Smith & Nephew, a global medical devices company with its United States headquarters in Memphis, Tennessee, issued a voluntary knee implant recall for the cementless versions of its Oxinium, Genesis II and Profix II knee implants from the U.S. market. The knee implant recall was due to the products not bonding properly causing some patients to undergo revision surgery. In addition to having a revision surgery, patients are also at an increased risk for other complications, such as infection, further joint and muscular damage and painful rehabilitation.
According to a Smith & Nephew spokesman, at the time of the knee replacement recall, only about 30 patients fitted with the cementless versions of the implants in the United States required revision surgery after the implants became loose. The company indicated that about 3,000 patients in the United States have received one of the three cementless implants. However, complications with the implants may still arise in other patients requiring more revision surgeries.
Knee replacement surgery is the most popular replacement surgery in the United States. Millions of people have undergone knee replacement surgery since it was introduced in its current form in the 1970s. There are approximately 200,000 to 300,000 knee replacement procedures performed every year in the United States and knee replacement surgery is only expected to become more popular. Considered a major elective surgery, the results of knee replacement surgery can be dramatic, though the risks can be as well.
People usually undergo knee replacement surgery when the pain has become too severe and no physical therapy or drug treatments are working. While a total knee replacement has a significantly higher success rate than in the past, complications can still arise. The success rate of the replacement operation is greatly influenced by the actual knee replacement that the patient receives.
The response to the knee replacement recall resulted in a number of lawsuits being filed, with more expected. The lawsuits sought damages for the revision surgeries and the risks of re-infection and further joint and muscular damage that could result in a more painful rehabilitation process. Rehab for knee replacement surgery is necessary in order to regain motion and strength. When the surgical procedure has complications, the rehab process can take longer than a couple months and pain is still experienced. The news of the Smith & Nephew recall angered many patients that had been battling a frustrating knee problem.