Zimmer Low Density Polyethylene (LDPE) Bag Adhesion
Healthcare professional
Medical devices
7 November 2013
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Zimmer Pte Ltd would like to inform healthcare professionals on the use of a subset of highly polished implants that were packaged in a low density polyethylene (LDPE) bag. Zimmer has received complaints that the LDPE bags containing the implant adheres to the highly polished implant surface. The frequency of this occurrence is approximately 1 in 8,000 cases. The level of adhesion of the old LDPE bag to the highly polished surface of the implants can vary, with material transfer to the implants ranging from residues to pieces of film. The evaluation of the potential risks associated with this event shows that it is unlikely that the adhesion of the LDPE bag would cause adverse effects to the patient or function of the implant. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more 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.
