Stryker has initiated a voluntary medical device product field action for the LFIT Anatomic CoCr V40 Femoral Head. The urgent field safety notice (RA 2016-028) can be found on the Medicines & Healthcare products Regulatory Agency (MHRA) website. The recall in the UK follows a recall notification in Canada and a hazard alert in Australia.
The reason for the recall is that Stryker has received higher than expected complaints of taper lock failure on certain femoral heads manufactured between 1 January 2002 and 4 March 2011. The taper lock connects the femoral head to the femoral neck, the main segment of the hip replacement. Stryker has reported that in the event the taper lock fails, patients may suffer serious problems including dislocation, hip stem fractures, adverse local tissue reaction, loss of mobility and joint instability. Should these problems arise, patients are likely to require revision surgery.
Elise Bevan, a solicitor in the product liability team at Penningtons Manches LLP, said: “Stryker has advised that those patients who have been fitted with the implant should be followed up in the usual way. However, if you are concerned that you may be affected, then you should contact your GP or surgeon for advice. If you have experienced a complication as a result of taper lock failure, we would be happy to discuss this further with you to assess whether you may have a claim for compensation.”