Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: MHRA updated recommendations for the management of patients implanted with metal-on-metal hip replacements

27 Jun 2012

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom issued a medical device alert which provided updated information and advice about the management and monitoring of patients implanted with metal-on-metal (MoM) hip replacements.

Most of the patients implanted with MoM hip replacements have well functioning hips, however, a small number of patients implanted with these hips may develop progressive soft tissue reactions to the wear debris associated with MoM articulations. The debris can cause soft tissue necrosis and adversely affect the results of revision surgery.

The MHRA issued an updated advice following extensive consultations with their clinical orthopaedic experts. This advice updates the recommendations for patients given in the previous medical device alerts.

For details, please refer to the following MHRA website: 
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/index.htm

Posted on 27 June 2012

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