Smith & Nephew has issued a safety alert for its Birmingham Hip modular head implant components. The company issued the Birmingham modular head implant warning after data from 2 overseas device tracking data since 2010 indicated that the metal-on-metal hip replacement components were failing at a rate higher than the bench mark established by the UK National Institute for Health and Clinical Excellence.
The components subject to the safety alert are part of Smith and Nephews Birmingham Hip implant line. The Birmingham line was introduced in 1987 in the UK, and was the first metal-on-metal hip replacement system to come to market. Smith and Nephew has not recalled the Birmingham Hip implant components, but has updated indications for their use. When used only with Smith and Nephews synergy stems, the failure rate for the Birmingham hip modular head implant component falls within acceptable limits, the company said.
The “ urgent field safety notice’’ was prompted by Data from Device registries in the UK and Australia. Data gathered since 2010 from the National Joint Registry of England and Wales indicated that the Birmingham Hip replacement components were failing at a rate of 1.29%. The Australian Orthopaedic Associations National Joint Replacement Registry put the failure rate at 1.12%. The UK’s NIHCE is 1%.
Potential complications associated with the Smith and Nephew components include pain and limited mobility, potentially leading to revision surgery. Women of child bearing age and severely over weight patients are at the greatest risk for Birmingham hip implant complications, the company said. Smith and 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 re-surfacing femoral component is being revised, the patient shows no signs of metal sensitivity, and it is being implanted in conjunction with an un-cemented synergy stem’’, according to the company’s website.
The introduction of the Birmingham Hip replacement line prompted other medical device makers to quickly bring their versions of metal-on-metal hip implants to the market, including the zimmer durom cup, and DePuy’s ASR and Pinnacle devices.
Metal-on-metal hip implants have been named in a growing number of legal cases amid concerns that the devices can shed dangerous amounts of metal debris in patients leading to premature implant failure, adverse local tissue reactions, metallosis and other long term health problems.
Last May, the US Health Authority ordered 21 manufacturers of metal-on-metal hip replacements, including biomet to conduct post-market studies of the products to determine whether 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, in that metal-on-metal hip implant patients undergo regular monitoring to ensure their devices are not failing.