Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00928-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-12
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00928-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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