UNITED KINGDOM — Medical device manufacturer Smith & Nephew has voluntarily removed from the market several components for its metal-on-metal hip implants.
The company removed from the market smaller-sized components and instructions for its metal-on-metal hip implants. Specifically, the company announced the removal from the market of “46 mm diameter and smaller femoral heads and corresponding acetabular cup components” for its Birmingham Hip Resurfacing System and the attached instructions for use.
Despite the voluntary removal, the company did not advise any action from patients or changes to patient care. Patients should seek proactive care if they are in pain or suffering from a failing implant. It did, however, suggest that patients with hip implants involving a femoral head size smaller than 46mm may be at greater risk for revision surgery. It is for this reason that the company is removing the smaller sizes from the market and updating its “instructions for use.”
This latest voluntary removal is not the first time Smith & Nephew has been under hot water for its metal-on-metal hip implants. In 2012, the company initiated a global recall of the metal liner for its R3 Acetabular System. This recall was issued because the liner was found to easily loosen, fail, and cause pain and other health complications at a much higher rate than normally expected amongst metal-on-metal hip implants. In fact, it was found that the R3 Acetabular System failed at a rate of 6.3 percent in four years compared to the average rate of 2.89 percent.
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