Events

Recall of NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

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-00698-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00698-1
  • 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 is initiating a hazard alert for specific lots already implanted due to the potential that the threads may be out of specification. zimmer received twelve complaints over a period of two and a half years alleging difficulty threading an mis drop down stem extension or a drop down stem plug into the mis stemmed tibial component. there were no complaints received from australia. the potential risks for this issue are: · additional bone loss may occur if the mis tibial is cemented in place when the issue is identified and the surgeon elects to remove and replace.· early revision may occur due to loosening (if the mis stemmed tibial component is implanted without a drop down stem extension), and/or infection.· disassociation of the implanted articular surface may occur if the stem extension does not fully seat, thus causing the articular surface to not properly lock.
  • Action
    Zimmer is providing surgeons with details of the potential risks associated with out of specification thread. For patients implanted with a potentially affected device, Zimmer recommends continued normal post-operative follow-up. For more details, please see http://www.tga.gov.au/safety/alerts-device-nexgen-complete-knee-solution-140709.htm .

Device

NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat
  • Model / Serial
    NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, PrecoatVarious sizes ARTG Number: 96761
  • 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