Dear Healthcare Professional Letters
Risk of ceramic fragments from fractured ceramic components of hip prostheses remaining in the joint during revision surgery
Audiences
Healthcare professional
Product type
Medical devices
27 September 2016
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Smith & Nephew Pte Ltd would like to alert healthcare professionals on the Field Safety Corrective Action related to Smith & Nephew Hip Prostheses with ceramic components (i.e. BIOLOX® DELTA & BIOLOX® FORTE). Recent post-market surveillance suggests the ceramic fragments from fractured ceramic components of hip prostheses may remain in the joint during revision surgery, which can lead to premature wear in revision components if such revision components are made of non-ceramic materials. This can lead to a need for an additional revision surgery. A safety warning has been issued by Smith & Nephew to caution against the use of non-ceramic components for revising fractured ceramic components used in hip arthroplasty. Please refer to the letter for details.
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.