By: Irvin Jackson | Published: June 4th, 2012
Reports of infections, dislocations and other problems have led Smith & Nephew to issue a recall for one of its metal-on-metal hip replacement components.
The Smith & Nephew R3 Acetabular System metal liner was recalled by the medical device manufacturer on June 1, after an analysis found that 1.6% of patients who received the liner underwent revision surgery each year.
Smith & Nephew officials indicate that the recall was not related to other problems known to affect metal-on-metal hip replacements, such as metallosis and catastrophic failure.
Problems with the Smith & Nephew hip replacements featuring the metal R3 liner component appear to involve infections, fractures and dislocations, and the failure rate was above the acceptable rate set by the U.K. of 1 percent.
The recall affects only the optional metal liners for the Smith & Nephew R3 Acetabular System. Other optional liners are not affected. The company estimates that about 7,700 of the recalled liners have been implanted in patients nationwide since it was first introduced in 2007 and then globally launched in 2009.
“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” said Andy Weymann, the company’s chief medical officer, in a press release. “As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon.”
Both in the United States and abroad, there are a growing number of medical experts who have indicated that all metal-on-metal hip replacement systems are unsafe and should be recalled from the market. As the metal parts rub against each other, they may release microscopic shavings of metal which could increase the risk of the artificial hip failing within a few years.
The FDA has scheduled a meeting of its orthopedic devices advisory board to review the safety of metal hip systems for later this month. The committee is charged with discussing failure rates associated with metal-on-metal hip replacements, testing for metal ion blood poisoning, imaging methods, local and systemic complications, patient risk factors and considerations for follow-up after surgery. The committee will then make recommendations to the FDA on how to proceed. The agency notes that it is considering whether to make metal-on-metal hip systems “subject to more rigorous testing and premarket review requirements.”