Events

Rappel de ADVANCE HA Coated Titanium Tibial Bases, all sizes

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Surgical Specialties 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-00883-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • 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-00883-1
  • 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
    In october 2015, the aoajnrr annual report indicated that the implant was experiencing higher than expected revision rates of 1.37 revisions per 100 observed years. the cumulative percent revision of the implant at 10 years is 11.8% compared to 5.5% for other knee implants. further analysis showed that a large proportion of the revisions (46.9% of revisions, 2.3% of primary procedures) were due to loosening/lysis, and that the advance ha coated tibial base was contributing to the higher rate and therefore microport has decided to remove this device from the market. advance ha coated tibial bases have not been used in australia since 2013 and have been withdrawn from the australian register of therapeutic goods (artg).
  • Action
    MicroPort Orthopaedics Pty Ltd is contacting surgeons to make them aware of this issue with the advice that the likelihood of a patient experiencing a postoperative loosening is very low. Should a patient experience sudden pain, instability, difficulty walking and/or performing common tasks, a tibial loosening can be confirmed via x-ray. A loosened tibial base may require removal through revision surgery. For more details, please see https://www.tga.gov.au/alert/advance-ha-coated-tibial-bases . This action has been closed-out on 24/05/2017.

Device

ADVANCE HA Coated Titanium Tibial Bases, all sizes
  • Modèle / numéro de série
    ADVANCE HA Coated TitaniumTibial Bases, all sizesPart Numbers: KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, KTTIHA50, KTTIHA51, KTTIHA60All Lots
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd