Events

Rappel de Sterile-Packaged Knee Implants

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-00660-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-19
  • 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-00660-1
  • 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
    An issue has been detected with the foil pouches of specific lots of sterile trabecular metal implants that were manufactured between april 2011 and october 2012. retrospective testing performed by zimmer biomet as a result of an internal review of the packaging system revealed that in some instances, tears/holes in some of the foil pouches were present in either the inner foil pouch or the outer foil pouch, but never both in the same sample. no product complaints have been reported for this issue. the affected product was distributed between april 2011 and march 2016.In a worst case scenario, if an issue with the foil pouch is detected during surgery, this will result in a slight delay to obtain another implant. if there is an issue with the foil pouch that goes undetected and also has resulted in a loss of sterility, a peri-prosthetic infection may occur. the risk associated with a peri-prosthetic infection is a revision or potential multi-stage revision to treat the infection.
  • Action
    Peri-prosthetic infections associated with the device/surgical site are most likely to manifest within 12 months of the device being implanted. Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. This action has been closed-out on 27/01/2017.

Device

Sterile-Packaged Knee Implants
  • Modèle / numéro de série
    Sterile-Packaged Knee Implants Part Numbers: 00-5878-065-35, 00-5878-065-41, 00-5886-043-12, 00-5886-043-14, 00-5886-045-12, 00-5886-047-17, 00-5886-048-12, 00-5886-056-10, 00-5886-064-12Multiple Products and Lot Numbers affectedARTG Numbers: 227807, 228177, 226498
  • 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