Events

Rappel de PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the femoral head/stem prosthesis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Wright Medical 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-2015-RN-00737-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-19
  • 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-2015-RN-00737-1
  • 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
    Microport orthopaedics inc. has identified unanticipated postoperative implant fractures related to this specific part number. these fractures are extremely rare, yet there have been 27 reports (failure rate of 0.275%) of fracture of the phac1254 component. all fractures involve part number phac1254 (long 8-degree varus) which sees the highest bending force due to its length and therefore represents the implant in this product family with the lowest mechanical strength under clinical conditions. no implant fractures have been reported in other pro femur cocr modular neck models. in the event the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks.
  • Action
    Surgeons are advised that there is no evidence fractures can be anticipated by visual inspection or during surgery. When the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks. A break will require revision surgery to correct. Should a patient present with sudden pain, instability and difficulty walking/performing common tasks a postoperative fracture can be confirmed via x-ray. No additional patient follow-up is required however surgeons are advised to discuss the issues with their patients . This action has been closed-out on 04/05/2017.

Device

PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the...
  • Modèle / numéro de série
    PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the femoral head/stem prosthesis) All lot numbersARTG number: 234443
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd