Events

Recall of Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty)

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-2016-RN-00928-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00928-1
  • 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
    The avenir müller stem 6 lateral uncemented may have been placed in the packaging of the avenir müller stem 4 standard uncemented and vice versa.The surgeon may have used a standard stem instead of a lateral stem. for the standard stem the offset is 6mm smaller and therefore an increased laxity of the hip might result. this could conduct to a risk of luxation, pain or revision surgery.
  • Action
    Zimmer is advising users that use of a standard stem instead of a lateral stem may result in an increased laxity of the hip, and may result in pain or revision surgery. This action has been closed-out on 17/02/2017.

Device

Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the...
  • Model / Serial
    Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty)Avenir Müller Stem 6 Lateral uncemented Reference Number: 01.06010.106Lot Number: 4023094Avenir Müller Stem 4 Standard uncementedReference Number: 01.06010.004Lot Number: 4022860ARTG Number: 216175
  • 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