Metal hip implants recalled by maker

The medical device maker Smith & Nephew has issued a recall for part of one of its hip replacement systems.

The recall follows reports of increased levels of infections, fractures, and dislocations linked to the metal liner component of its R3 Acetabular System.

The number of Irish recipients of this component is less than 30, according to the Irish Medicines Board which, at this stage, is not recommending any changes to follow-up care.

All-metal hip implants have been the subject of safety concerns since the global recall in Aug 2010 of the DePuy Orthopaedic ASR hip implant.

About 7,700 metal liners have been implanted since the component was introduced in 2007.

The majority of these have been used in stemmed total hip replacements.

All-metal replacements can shed minute particles of cobalt and chromium into surrounding tissue and a patient’s bloodstream. This can lead to metallosis, the build-up of metal debris in a patient’s body that can lead to significant adverse effects.

Smith & Nephew says despite reports of infections and other problems, there is no evidence of metallosis.

The decision to withdraw the device came after a review of clinical results showed 1.6% of patients implanted with the system required revision surgery annually, above the 1% guideline set by Britain’s National Institute for Health and Clinical Excellence.

In a statement, the IMB said: “Smith and Nephew has confirmed to the IMB that the implanting hospitals have been advised of the recall.”

The IMB is “monitoring the recall and to date has had no reported adverse events associated with this product”.

Smith & Nephew were unavailable for comment.

Liam Moloney, product liability solicitor, said: “The IMB should act immediately to ensure that all patients who received this medical device have been alerted about this recall.

“The company should also pay for all necessary follow up procedures, X-rays and blood tests.”