Events

Recall of Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration)

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-2014-RN-00111-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00111-1
  • 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
    Zimmer has received 13 complaints since 2007 related to hyper-extension. this represents a complaint rate of approximately 0.4%. of the 13 complaints there were 9 patients involved due to repeat occurrences with multiple patients. in addition, analysis of the explanted polyethylene insert found that it typically exhibited anterior deformation in these 9 patients. based on the investigation of these complaints, zimmer determined that updates to the labelling associated with the zimmer segmental system were required to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
  • Action
    Zimmer is updating the applicable surgical technique (97-5850-004-00) and instructions for use (87-6203-755-23) and is advising surgeons that if a patient is symptomatic with instability or pain associated with hyperextension of approximately 15 degrees or more, surgeon evaluation is recommended. Zimmer is also working on an enhanced design that will be offered in addition to the current polyethylene inserts.

Device

Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal fem...
  • Model / Serial
    Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration) Item Numbers: 00-5850-012-95 & 00-5850-013-95ARTG Number: 198424
  • 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