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SMITH AND NEPHEW ANNOUNCE RECALL OF R3 ACETABULAR HIP COMPONENTS
The Medicines Healthcare Regulatory Authority, the body which regulates medical devices in the UK, has issued a Medical Device Alert in the relation to the R3 acetabular system manufactured by Smith and Nephew Orthopaedics Ltd.
The R3 system consists of a metal liner used in Metal on Metal (MoM) hip replacements and has been shown to be associated with increased revision rates. 6.3% of implants using the R3 system have been found to require replacement. Usually, only 4% would be expected to require revision.
This increase is considered to be significant and surgeons in the UK have been told to stop using the R3 system.
Smith and Nephew themselves issued a recall notice which prompted the action from the MHRA.
The guidance from the MHRA can be viewed by clicking HERE
It is believed the 281 patients have been fitted with these components in the UK and are now to be subject to close annual monitoring for signs of complications such as pain or swelling.
Christian Beadell, an Associate Solicitor in the Clinical Negligence department is dealing with a number of claims involving Smith and Nephew MoM implants and commented on the latest news:
“This is yet further evidence that Metal on Metal hip implants are not as safe and reliable as previously believed. The widespread concerns in relation to the DePuy implants have, up until now, bypassed Smith and Nephew , but these latest developments will bring them and their resurfacing implants under closer scrutiny.
I can only hope that those patients who have had the R3 system will be contacted and receive the support and medical input that they need. If complications do arise, then I would expect Smith and Nephew to ensure that the implants are extracted quickly and at no costs to the patients’ as we have seen with some of the other MoM hip implant manufacturers.”
If you are affected by this news item or any of the issues that it addresses and wish to discuss your concerns then please contact us.
The team have many years experience of claims of this nature and are always happy to help and advise. For more information please contact us on 0800 073 0385 (0151 257 6000) or by email at FRT@goodmanslaw.co.uk.
Our First Response Team is available from 8am to 8pm every business day.
Goodmans Law are specialists in dealing with clinical negligence and personal injury claims.
