Thursday, June 07, 2012
Smith & Nephew Recalls Hip Device Component
Smith & Nephew is voluntarily taking the metal liner component of its R3 Acetabular System off the market. The company claimed that it was “not satisfied with the clinical results” of the liner, with one spokeswoman reportedly stating that an uptick in revisionary surgeries prompted the recall.
According to reports, approximately 7700 of the liners were implanted in patients since their introduction into the marketplace. It has been reported that the liner was associated with infections, performance issues and fractures, among other problems. According to a company spokeswoman, metallosis, a type of poisoning linked to metal-on-metal implants, was not among the issues that necessitated the recall.
Over the past several years, a number of metal-on-metal hip implants, including the recalled DePuy ASR devices, have been linked to metal poisoning and premature failure. A recent study from the National Joint Registry of England and Wales revealed that 6% of patients implanted with metal-on-metal hip implants required further surgery to replace or repair the devices after five years, compared with 1.7 to 2.3% of those implanted with a plastic or ceramic device. It has also been reported that patients implanted with metal-on-metal hips have shown high levels of metal ions in their bloodstream, which are released when the metal components move against each other. Excessive levels of cobalt have been linked to a number of health problems, while muscles and soft tissue damaged by the body’s inflammatory response to the metallic debris may compromise revision surgery.