|Date:||2 April 2012|
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The Medicines and Healthcare products Regulatory Agency (MHRA) today issued advice to surgeons to stop using a particular combination of metal-on-metal total hip replacements because it has a high revision rate compared with other implants. The MHRA has also advised surgeons to closely monitor patients with this combination of implants.
The advice is included in a new MHRA Medical Device Alert that has been issued to clinicians today for the management of patients the Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination with Accolade femoral stems made by Stryker Orthopaedics.
Surgeons are being advised to stop using this combination of hip replacements because information from the England and Wales National Joint Registry (NJR) shows that it has an unacceptably high revision rate of 10.7 percent after four years of implantation. The MHRA is advising surgeons to follow up with patients with this combination of devices as we previously advised in February 2012.
The MITCH TRH hip is a metal-on-metal hip replacement system consisting of components which can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. Patients with the MITCH TRH resurfacing implants are not affected by this latest notification. There are around 270 people with this combination in England and Wales according to the NJR.
Dr Susanne Ludgate, Clinical Director of the MHRA, said:
“The majority of patients implanted with metal-on-metal hip replacements have well functioning hips and are at a low risk of developing any serious problems. Patients with metal-on-metal hip replacements should already be regularly monitored by their clinician.
“Analysis has shown that the revision rate for this combination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely.
“We have previously taken prompt action in February to investigate safety concerns and provided advice on patient management to relevant healthcare professionals."
Notes to Editor
- Advice issued to patients in February 2012:
- The MHRA takes its post-market surveillance role very seriously and works with other Member States to ensure that only compliant medical devices are placed on the market. Following reports of problems with large metal-on-metal hip replacement/resurfacing in the late 2000s the National Joint Registry, the British Orthopaedic Association, the British Hip Society and the MHRA formed a close working relationship as an expert advisory committee to investigate the possibility of potential problems associated with some of these types of joint replacements. Whilst there had been reports from other countries, the UK was the first in the world to issue guidance through its regulatory authority the MHRA as a result of these closer working practices. Other counties have now followed this lead.
- The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.