Smith & Nephew has issued a safety alert for its Birmingham Hip Modular Head implant components. According to a report from MassDevice.com, Smith & Nephew issued the Birmingham Modular Head implant warning after data from two overseas device tracking databases since 2010 indicated the metal-on-metal hip replacement components were failing at a rate higher than the benchmark established by the U.K.’s National Institute for Health and Clinical Excellence.
The components subject to the alert are part of Smith & Nephew’s Birmingham hip implant line. The Birmingham line was introduced in 1997 in the U.K, and was the first metal-on-metal hip replacement system to come to market. According to Mass Device, Smith & Nephew has not recalled the Birmingham hip implant components, but has updated indications for their use. When used only with Smith & Nephew’s Synergy stems, the failure rate for the Birmingham Hip Modular Head implant components falls within acceptable limits, the company said.
The “Urgent Field Safety Notice” was prompted by data from device registries in the U.K. and Australia. Data gathered since 2010 from the National Joint Registry of England and Wales indicated the Birmingham hip replacement components were failing at a rate of 1.29%. The Australian Orthopaedic Association’s National Joint Replacement Registry put the failure rate at 1.12%. The U.K.’s National Institute for Health and Clinical Excellence is 1%, according to Mass Device.
Potential complications associated with the Smith & Nephew components include pain and limited mobility, potentially leading to revision surgery. Women of child bearing age and severely overweight individuals are at the greatest risk for Birmingham hip implant complications, the company said. Smith & Nephew has revised the indications for use to state that use of Birmingham Hip Modular Heads should be restricted only to revision surgeries “in cases where a Birmingham Hip Resurfacing femoral component is being revised, the patient shows no signs of metal sensitivity, and it is being implanted in conjunction with an uncemented Synergy stem,” according to the company website.
As we’ve reported previously, the introduction of the Birmingham hip replacement line prompted other device makers to quickly bring their versions of metal-on-metal hip implants to market, including the Zimmer Durom Cup, and DePuy’s ASR and Pinnacle devices. Over the summer, Mass Device reported that one of Smith & Nephew’s rivals, Wright Medical Inc., had challenged the company’s 2006 application for U.S. Food & Drug Administration (FDA) approval of the Birmingham, claiming the study used to back Smith & Nephew’s application was inadequate to prove safety and efficacy.
The FDA eventually granted two pre-market approvals for the Birmingham, first in May 2006 and another in October of that year for additional sizes.
Metal-on-Metal hip implants have been named in a growing number of lawsuits amid concerns that the devices can shed dangerous amounts of metal debris in patients, leading to premature implant failure, adverse local tissue reactions, metallosis, pseudotumor formation and other long-term health problems. Last May, the FDA ordered 21 manufacturers of metal-on-metal hip replacements, including Biomet, to conduct post-market studies of their products to determine if they were putting patients at risk. Over the summer, a panel of FDA advisors recommended that new warnings be included on the labels for such devices, and that metal-on-metal hip implant patients undergo regular monitoring to ensure their devices are not failing.