MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice

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The Medicines & Healthcare products Regulatory Agency (MHRA) has today issued new advice to surgeons that they should not use a particular type of metal cup liner that is used in some metal-on-metal hip replacement operations.

A Medical Device Alert was issued today by the MHRA following a product recall by manufacturer Smith & Nephew of the R3 metal cup liner component of the R3 Acetabular System. The R3 metal cup liner is used with appropriate Smith & Nephew hip replacement femoral components.

Post-market surveillance data has shown a high revision rate of 6.3% at four years for patients implanted with the R3 metal liner. This high revision rate is not in line with the 4% guidance figure at four years from the National Institute of Health and Clinical Excellence (NICE) and therefore the MHRA has told surgeons to stop using the metal cup liner and to annually monitor the 281 patients who have been fitted with these cup liners so that any complications such as pain or swelling are picked up and treated early.

The MHRA also issued updated advice today to surgeons about extending the period of follow-up to annual monitoring of their patients if they are experiencing complications such as pain or swelling from their metal-on-metal hip resurfacing implants or metal-on-metal hip replacements that have a head diameter below 36 millimetres. The new advice of annual monitoring replaces previous patient monitoring advice for these size of implants that patients should be followed up for a minimum of five years.

Today’s new information is viewed as a routine patient monitoring advice update by the independent expert advisory group that was set up by the MHRA to look at the management of patients with metal-on-metal hip implants. There is no new evidence of an increased safety risk associated with metal-on-metal hip implants and people with these implants who are not experiencing any problems do not need annual monitoring

Dr Susanne Ludgate, the MHRA’s Clinical Director of Medical Devices, said:

“In the UK, 281 patients have been fitted with this specific R3 metal cup liner. Evidence from post market surveillance data has shown that the revision rate for this implant is high and that is why we have taken action to advise surgeons to stop using this device and to monitor the patients implanted with this cup liner on an annual basis.

“Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants but we believe, after advice from our expert advisory group, that it makes sense for surgeons to annually monitor any patients who are showing any symptoms such as pain or swelling if they have metal-on-metal hip implants. By monitoring patients with symptoms every year, any complications will get picked up and they can be treated earlier.”

Notes to Editor

1. The Medical Device Alert on the R3 metal cup liner can be viewed here:

Medical Device Alert: Metal-on-metal (MoM) hip replacements: Metal liner component of the R3 acetabular system manufactured by Smith & Nephew Orthopaedics Ltd. (MDA/2012/035)

2. The Medical Device Alert on the updated patient monitoring advice can be viewed here:

Medical Device Alert: All metal-on-metal (MoM) hip replacements (MDA/2012/036)

3. The updated patient monitoring advice concerns metal-on-metal hip resurfacing devices and metal-on-metal hip replacements that head diameter below 36 millimetres. This is in addition and different to patient monitoring advice we issued on 28 February 2012 for large metal-on-metal total hip replacements with a head diameter of 36mm or more. This is available using the link below:

Press release: MHRA updates advice for metal-on-metal hip replacements

4. The MHRA was the first regulatory agency in the world to issue advice to clinicians about metal-on-metal hip implants in April 2010 and we, in combination with our expert advisory group, are continuing to closely monitor all the latest evidence about these devices. If patients have any questions, they should speak to their surgeon or doctor.

5. 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 1990s 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.

via Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice : MHRA.

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