Urgent Field Safety Notice on Birmingham Hip™ Modular Heads (Monoblock and Sleeved)

Smith and Nephew has informed doctors of a field safety corrective action (FSCA) relating to the BIRMINGHAM HIP™ Modular Heads (BHMH), whereby the device’s indication for use and contraindications will be revised. The Australian National Joint Replacement Registry (NJRR) and the National Joint Registry of England and Wales (NJREW) have reported the BHMH, as part of a Total Conventional Hip Replacement system, to have a higher than expected revision rates when compared to all other total conventional hip replacements. Most of the revisions occurring in the last three years were linked to metal sensitivity and infection. As a result, Smith & Nephew has decided that the BHMH should no longer be used for primary total hip replacement surgery. Doctors are advised to refer to the Field Safety Notice (FSN) for additional information on the revised indications for use, contraindications and advice on patient management. As the proposed changes have not been submitted to the Authority in a Change Notification application and the changes have not been approved, HSA does not endorse any of the advice provided in the FSN, including the proposed changes to the Instructions for Use.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.