Zimmer® Segmental System Polyethylene Insert-Size B & Size C

Zimmer Pte Ltd would like to inform healthcare professionals of the field safety corrective action for Zimmer Segmental System Polyethylene Insert (Size B & Size C) due to the occurrence of hyper-extension in patients with the affected devices. Zimmer has received 13 complaints involving 9 patients where the polyethylene insert exhibited anterior deformation. Hyper-extension of the polyethylene inserts can lead to risks, as well as increased pain, associated with revision surgeries. Based on Zimmer's investigations, it was determined that additional instructions, including information on patient conditions that may place excessive loading on the polyethylene insert, were required to be updated in the surgical technique and instructions for use for the Zimmer Segmental System. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more details.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on 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://www.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 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.