Risk of oxidation of Exactech Optatrek Patella implants with defective packaging

The Health Sciences Authority (HSA) would like to alert healthcare professionals about the possible risks associated with specific Optetrak Patella implants manufactured by Exactech, Inc. between 2004 and August 2021. These implants were packaged in non-conforming packaging bags without an oxygen barrier layer which can result in unintended oxidation and early degradation of affected devices. Healthcare professionals are advised not to implant any of these affected Optetrak Patella devices and monitor patients implanted with the devices for potential device wear, failure, component cracking or fracture, new or worsening pain, bone loss and/or swelling. Where device failure is suspected, further evaluation by x-ray examination should be considered. Revision of a well-functioning device from patients who are not experiencing new or worsening symptoms is not recommended. 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.