Smith & Nephew has initiated a voluntary recall for all lots of the Modular Neck Hip Prostheses of the Modular SMF™ and Modular REDAPT™ Revision Femoral Hip Systems. The associated stems will also be removed from the market. The affected devices were shipped between October 2008 and July 2016.
The recall is due to a higher than anticipated complaint and adverse event trend. There are reports that implanted patients exhibit symptoms of adverse tissue reaction to metal debris, leading to the need for revision surgery, at a rate higher than for comparable hip prostheses. This information comes after a recent review of product complaints received by Smith & Nephew and data from a clinical study.
Elise Bevan, a solicitor in the product liability team at Penningtons Manches LLP, said: “The advice issued is that doctors should maintain their routine follow-up protocol for patients who have undergone hip surgery and continue to monitor them for pain, swelling and limited mobility. For patients that do display symptoms, it is recommended that a blood test is done to check for raised cobalt and chromium ions or that a scan is undertaken to evaluate further whether there has been a soft tissue reaction. Smith & Nephew is not advising that patients undergo pro-active revision surgery, but if there is evidence of an adverse reaction to metal debris, then this is advised.
“Our specialist team is dealing with a number of metal-on-metal hip claims. If you have experienced any problems as a result of a Smith & Nephew hip prosthesis, we would be happy to discuss this further with you to assess whether you may have a claim for compensation.”
The urgent field safety notice (R 2016-048) can be found on the Medicines & Healthcare products Regulatory Agency (MHRA) website.