Events

Rappel de Zimmer NexGen Micro Knee Implants (Femur, Patella, Articular Surface) and Provisionals

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-2013-RN-00639-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-10
  • 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-2013-RN-00639-1
  • 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
    This matter is a follow up to the safety alert issued in march 2012 (rc-2012-rn-00366-3) related to a component compatibility issue with the nexgen cruciate retaining (cr) complete knee system. specifically, zimmer had received complaints where a nexgen cr micro articular surface was used with a cr standard femur, even though the compatibility chart indicates that these combinations are not approved. since the safety alert was issued, zimmer has monitored the occurrence of non-compatible micro component combinations being implanted. this included the usage of micro femurs and micro patellae, in addition to micro articular surfaces. although the occurrence has been reduced since the 2012 safety alert, it has not been eliminated and therefore zimmer is initiating a recall to remove the affected devices from the market. surgeons who have implanted the wrong combinations are provided with this information through a hazard alert so that the affected patients can be appropriately managed.
  • Action
    Zimmer is asking customers to inspect stock and quarantine any of the affected stock, to be collected by a Zimmer sales representative. Surgeons who have implanted the wrong combinations are provided with the information so that the affected patients can be appropriately managed. For more details, please see http://www.tga.gov.au/safety/alerts-device-nexgen-130731.htm .

Device

Zimmer NexGen Micro Knee Implants (Femur, Patella, Articular Surface) and Provisionals
  • Modèle / numéro de série
    Zimmer NexGen Micro Knee Implants (Femur, Patella, Articular Surface) and ProvisionalsMultiple part numbers and component types
  • 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