Events

Rappel de Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)

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-00985-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-09-25
  • 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-00985-1
  • 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
    Residue or pieces of film from the ldpe bag containing the implant may adhere to the highly polished implant surface. the frequency of this occurrence is approximately 1 in 8000 cases. in a small number of these cases the affected device was implanted. testing and analysis were conducted to evaluate potential risks such as abrasive wear, mechanical integrity and biocompatibility. these evaluations concluded that it is unlikely that adhesion of the ldpe bag would cause an adverse effect to either the patient or function of the implant because:-the ldpe material is biocompatible, similar to the ultra high molecular weight polyethylene (uhmwpe).-ldpe is softer than the two mating material of uhmwpe & cobalt chrome molybdenum. therefore, is not expected to scratch either wear surface, which could increase wear rates and lead to osteolysis.-if there were wear particulates generated from the ldpe bag, they would be expected to elicit similar reactions as those from uhmwpe.
  • Action
    Zimmer is advising users to examine potentially affected implants prior to use. Should a user encounter adhesion of a LDPE bag to a implant during surgery, it is recommended that the implant not be used. The implant can be returned to a Zimmer sales representative.

Device

Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)
  • Modèle / numéro de série
    Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)All lots manufactured prior to 1 April 2013Multiple products affectedMultiple Part Numbers affectedARTG Numbers: 95692, 208688, 99906, 95760, 115909
  • 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