The medical device maker, Smith & Nephew has just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.
The recall followed reports of a “higher than normal level’’ of patient problems with the device which has been linked to the defective component. Smith & Nephew is withdrawing the optional metal liner which is a component of its R3 Acetabular system. Surgeons are able to continue using the system with alternative non-metal liners.
The problem with the component involves patients having increased levels of infections, fractures and dislocations. However, there was no evidence of metallosis, the build-up of metal debris in patients bodies that can lead to significant adverse effects.
The decision came after a review of clinical results showed that 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. Smith & Nephew are based in Britain and some 7,700 of the metal liners have been implanted since the component was released in 2007.
All-metal hip implants have been the subject of safety concerns since the August 2010 global recall of the DePuy Orthopaedic ASR hip implant. It is believed that all-metal hip replacements which consist of a metal acetabular cup and metal femoral head can shed minute particles of cobalt and chromium into surrounding tissue and even into a patient’s bloodstream leading to metallosis.
Speaking about the latest safety issue involving metal-on-metal hip systems, Liam Moloney Product Liability Solicitor said today “the Irish Medicines Board 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”.
He added “the IMB should carry out an analysis about the safety of all metal-on-metal hip devices to alert patients considering hip surgery of the risks associated with them”.
In 2007, Smith& Nephew recalled about 185 Birmingham hip resurfacing systems over improper packaging by a sub-contractor. The packaging error caused an array of different sized acetabular cups to be become mixed and mislabelled. A number of patients complained of having received wrong-sized hips which forced some to undergo a revision surgery to remove and replace the poorly fitting device.
5th June 2012
-ENDS–
For further info, Contact:
Liam Moloney Solicitor. O87 2726759/045 898000
