Events

Rappel de CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used for 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 MicroPort Orthopedics 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-2016-RN-00893-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-02
  • 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-2016-RN-00893-1
  • 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 orthopedics inc.’s international experience has shown an increasing overall trend in revisions from 2009 to present, and it was identified that there was a specific hazard/harm for “suspected tissue reaction to metal debris”. the potential for a patient reaction when implanted with metal on metal tha is a known risk for this product technology. the typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device.Microport metal on metal total hip replacements have not been used in australia since 2013 and have been cancelled from the australian register of therapeutic goods (artg). in australia, published information has shown few users with low revisions. for more information, please see https://www.Tga.Gov.Au/alert/microport-orthopedics-metal-metal-hip-implant-components .
  • Action
    MicroPort Orthopedics is contacting surgeons to make them aware of this issue. Rising levels in serial measurements of Cobalt and Chromium in blood, in conjunction with X-ray, MRI and ultrasound can be valuable in the follow-up of patients. Recipients of Total Conventional MoM implants with a large femoral head, and recipients of Total Resurfacing Implants who are female and/or have a small femoral head are at a higher risk of metal pathology related complications leading to revision. These patients should receive particularly close follow-up. The TGA has developed guidelines for the follow up of patients that have received a MoM hip replacement. These guidelines were developed in consultation with the Australian Orthopaedics Association and The Orthopaedics Sub Committee of the Advisory Committee on the Safety of Medical Devices, and can be found at: https://www.tga.gov.au/metal-metal-hip-replacement-implants .

Device

CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used f...
  • Modèle / numéro de série
    CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used for Metal on Metal (MoM) Total Hip Arthroplasty)All implanted lots
  • Manufacturer
    MicroPort Orthopedics Pty Ltd

Manufacturer

MicroPort Orthopedics Pty Ltd
  • Source
    DHTGA