Events

Rappel de SIGMA HP PFJ Cemented Trochlear 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 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-2018-RN-00005-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-09
  • 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-2018-RN-00005-1
  • 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
    The manufacturer, depuy orthopaedics, inc. is voluntarily recalling the sigma hp pfj cemented trochlear implants, which is a standalone component of the partial knee system. this decision is based on elevated revision rates observed as part of the company’s post market surveillance process. further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. the company recommends that surgeons use alternative implants or consider a total knee replacement.
  • Action
    DePuy is advising Recipients are requested to return a copy of the completed acknowledgement form as directed in the Hazard Alert and to forward this notice to anyone who needs to be informed. DePuy Orthopaedics, Inc. is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients who received the affected implants.

Device

SIGMA HP PFJ Cemented Trochlear Implants

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes