Events

Rappel de ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthroplasty)

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 Australia.

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-00054-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-25
  • 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-00054-1
  • 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
    Review of post-market surveillance data suggests a higher than expected revision rate for the adept® 12/14 modular head used in conventional total hip arthroplasty (tha). in september 2012 the aoa njrr reported a cumulative revision rate of 7.1% (95% ci 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of adept® cases (adept® cups used in conjunction with adept® 12/14 modular heads) used in conventional total hip arthroplasty. the identified reasons for the revisions are 4 loosening/lysis, 2 infections, 1 prosthesis dislocation and 1 pain. an analysis of uk njr data (download 11th november 2012) indicated a cumulative revision rate of 12.1% (95% ci 9.5% to 15.4%) at 7 years for the adept® 12/14 modular head when used in conventional total hip arthroplasty based on 109 revisions from 1582 recorded procedures. when this combination is used with the adept® cementless stem, the data showed a cumulative revision rate of 9.7% (95% ci 5.9% to 15.5%) at five years.
  • Action
    J&J; is advising implanting/treating surgeons on how to manage patients implanted with the Adept 12/14 Modular Head. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-ahm-130318.htm .

Device

ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthro...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia