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On February 28, 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issued an updated medical device alert regarding management of patients with metal-on-metal hip replacement devices. The alert is directed at healthcare providers who monitor patients with all-metal hip replacement implants. It is an update to a previous medical device alert regarding metal-on-metal hip implants that was released in April 2010.
Although the MHRA states that many patients have had favorable results with all-metal hip implants, the agency cites that there may be a risk of developing serious complications when implanted with this type of device. These complications can result from the wear debris released from the metal-on-metal implant, which may lead to soft tissue necrosis and the need for a revision surgery. MHRA states that early detection of these types of problems can lead to a more favorable revision surgery outcome.
The updated medical device alert recommends healthcare providers follow-up with metal-on-metal hip implant patients who were implanted with a 36 mm or greater femoral head annually for the life of the implant. The agency also recommends that healthcare providers follow-up with all DePuy ASR hip replacement patients annually for the life of the implant.
See the full MHRA medical device alert at:
http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con143787.pdf