|
 

MHRA Issues New Advice to Surgeons about Metal On Metal Total Hip Replacements

The Medicines and Healthcare products Regulatory Agency (MHRA) has 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 per cent after 4 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."

Updated patient monitoring advice on metal on metal hips (Here) was issued in February 2012.

qr code
 
 
About The Operating Theatre Journal

The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

More »
Follow & Share

Follow The Operating Theatre Journal on Facebook Follow The Operating Theatre Journal on Twitter Follow The Operating Theatre Journal on LinkedIn Follow The Operating Theatre Journal RSS Feed

Help & Support

Problems with, or comments about, this website may be emailed to:
webmaster@lawrand.com

Get in touch

Telephone: +44 (0)2921 680068
Skype: Lawrand Ltd
Email: admin@lawrand.com