We recently covered the news, here, that Smith & Nephew was withdrawing the metal liner of its R3 acetabular hip system. Now comes the news that MHRA has formalised the matter in its own inimitable way, by issuing a Medical Device Alert which includes guidance on care of the 281 UK patients known to have the product impanted in them.
Smith & Nephew’s analysis, using data from the National Joint Registry for England and Wales, has shown a high revision rate of 6.3% at four years for patients implanted with the R3 metal liner. This revision rate is not in line with the current guidance from the National Institute for Health and Clinical Excellence (NICE) and as such the company initiated a field safety notice including a recall, on June 1st 2012. That notice can be found here.
The MHRA’s Medical Device Alert directs clinicians and associated medical professionals to identify and isolate inventory for recall, not implant any of the identified products and furthermore identify and follow-up both symptomatic and asymptomatic patients implanted with affected devices as detailed later on in the Alert. Patient follow-up focuses on blood metal-ion testing in both symptomatic and asymptomatic groups with revision to be considered in the event that levels are seen to be rising, indicative of implant wear and associated soft tissue reaction.
The Alert can be found here.