lncreased risk of fracture of specific STAR Total Ankle Replacement polyethylene components due to polyethylene oxidation

A Dear Healthcare Professional Letter has been issued by Gen-Y (S) Pte Ltd to inform healthcare professionals that patients implanted with the STAR Total Ankle Replacement distributed prior to August 1, 2014 may experience a higher than expected risk of polyethylene fracture due to potential increase in polyethylene oxidation prior to or after implantation. Ambulation on the TAR (Total Ankle Replacement) after polyethylene fracture can damage the metal components of the total ankle replacement, requiring revision of the entire TAR. Healthcare professionals are advised to closely monitor patients implanted with the affected polyethylene component for follow-up and to be aware that the clinical presentation of polyethylene fracture can be subtle. If the integrity of the product is in question, x-rays are required. As the changes on x-rays can be subtle, polyethylene fracture may be ruled out with a computerized tomography (CT) scan. 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.