Events

Rappel de Durom Acetabular Component (Used for metal on metal hip replacements)

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-2012-RN-00907-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-04
  • 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-2012-RN-00907-1
  • 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
    Zimmer pty ltd withdrew the durom acetabular component from the australian market, with effect from 30th june 2011, due to a decline in sales. a hazard alert is being issued in response to the tga’s proposal to cancel the inclusion of the durom acetabular component from the artg based on the devices cumulative revision rate of 9.6% at 7 years in resurfacing applications and 6.8% at 5 years for total conventional hip replacements as reported in the 2011 national joint replacement registry (njrr) report.
  • Action
    Zimmer is advising implanting/treating surgeons on how to manage patients implanted with Durom Acetabular Components. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-dac-121030.htm

Device

Durom Acetabular Component (Used for metal on metal hip replacements)
  • Modèle / numéro de série
    Durom Acetabular Component (Used for metal on metal hip replacements)Previous ARTG Number: 100041
  • 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