Events

Rappel de Sirius Polish Cemented Stem 34B & Sirius Polish Cemented Stem 38C Sirius Polish Cemented Stem 34B

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomet Australia 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-2014-RN-01270-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-04
  • 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-2014-RN-01270-1
  • 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
    Following an investigation it has been identified that the component level lots were mixed during manufacturing. if the surgeon intended to implant a 34b but actually implanted a 38c, the potential adverse health outcome is a thin cement mantel which may lead to a revision, if the cement mantel were to crack. additionally, the vertical and horizontal offsets may be larger than expected which may cause the patient to have potential leg length discrepancy and improper soft tissue tension (too tight). if the surgeon intended to implant a 38c but actually implanted a 34b, the potential adverse health outcome is the vertical and horizontal offsets may be smaller than expected which may cause the patient to have potential leg length discrepancy.
  • Action
    Biomet is notifying surgeons of the safety implications of use of the incorrect size and advising surgeons to be aware of the issue during patient follow up. Further information can be found on the TGA web site at - http://www.tga.gov.au/alert/sirius-hip-stem-34b-and-38c-used-hip-replacements This action has been closed-out on 07/06/2016.

Device

Sirius Polish Cemented Stem 34B & Sirius Polish Cemented Stem 38C Sirius Polish Cemented Stem 34B
  • Modèle / numéro de série
    Sirius Polish Cemented Stem 34B & Sirius Polish Cemented Stem 38C Sirius Polish Cemented Stem 34B Part Number: 51-199333 Lot Number: 024320 Sirius Polish Cemented Stem 38C Part Number: 51-199335 Lot Numbers: 141680, 180920 ARTG number: 223604
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet Australia 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