The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning ADEPT 12/14 Modular Head, manufactured byDePuyOrthopaedics(a Johnson & Johnson company).
Review of post‐market surveillance data suggests a higher than expected revision rate for the ADEPT 12/14 Modular Head when used in conventional total hip arthroplasty.
Analysis of UK National Joint Registry Supplier Feedback data indicates a cumulative revision rate of 12.1% (95% CI 9.5% to 15.4%) at 7 years for the affected product when used in conventional total hip arthroplasty. In September 2012, the Australian Orthopaedic Association National Joint Replacement Registry reported a cumulative revision rate of 7.1% (95% CI 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of 121 ADEPT 12/14 Modular Head cases used in conventional total hip arthroplasty.
The manufacturer advises that patients who have received the affected products should be followed according to local guidance/standard of care for patients receiving metal on metal (MoM) articulations. Also, refer to the local orthopaedic association for detailed information related to the treatment of patients with MoM articulations.
For details, please refer to MHRA website:http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON224428
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 22 January 2013