Events

Recall of Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00985-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00985-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Residue or pieces of film from the ldpe bag containing the implant may adhere to the highly polished implant surface. the frequency of this occurrence is approximately 1 in 8000 cases. in a small number of these cases the affected device was implanted. testing and analysis were conducted to evaluate potential risks such as abrasive wear, mechanical integrity and biocompatibility. these evaluations concluded that it is unlikely that adhesion of the ldpe bag would cause an adverse effect to either the patient or function of the implant because:-the ldpe material is biocompatible, similar to the ultra high molecular weight polyethylene (uhmwpe).-ldpe is softer than the two mating material of uhmwpe & cobalt chrome molybdenum. therefore, is not expected to scratch either wear surface, which could increase wear rates and lead to osteolysis.-if there were wear particulates generated from the ldpe bag, they would be expected to elicit similar reactions as those from uhmwpe.
  • Action
    Zimmer is advising users to examine potentially affected implants prior to use. Should a user encounter adhesion of a LDPE bag to a implant during surgery, it is recommended that the implant not be used. The implant can be returned to a Zimmer sales representative.

Device

Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)
  • Model / Serial
    Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)All lots manufactured prior to 1 April 2013Multiple products affectedMultiple Part Numbers affectedARTG Numbers: 95692, 208688, 99906, 95760, 115909
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA