Events

Rappel de Apex K2 Modular Hip Replacement System (total joint 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 Global Orthopaedic Technology 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-2012-RN-01012-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-18
  • 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-2012-RN-01012-1
  • 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 annual reports of the australian national joint registry [njrr], have indicated a higher than expected revision rate for this prosthesis since 2010. the 2011 njrr report indicated that the cumulative revision rate for the device was 5.2% at 1 year from the time of implantation, and a headline revision rate of 4.6 revisions per 100 observed years. the revision rate for the implant continues to be higher than that of similar implants being used in australia. the apex k2 stem has not been available for implantation since early october 2011.This device has now also been cancelled from the australian register of therapeutic goods as well as the private hospital prosthesis list.
  • Action
    Global Orthopaedic Technology is advising implanting/treating surgeons on how to manage patients implanted with Apex K2 Femoral Stem. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-apex-k2-121030.htm

Device

Apex K2 Modular Hip Replacement System (total joint prosthesis)
  • Modèle / numéro de série
    Apex K2 Modular Hip Replacement System (total joint prosthesis)Multiple Catalogue NumbersPrevious ARTG Number: 149020
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd