Events

Rappel de GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew Surgical 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-00154-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-24
  • 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-00154-1
  • 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
    Batch number 14ct39993 of the genesis ii knee system non-porous tibial base plate (model # 71420182) were manufactured with a surface finish that does not meet smith & nephew’s product specification. this could result in poor cement adherence and the loosening of base plate. the device may fail, and revision surgery may be required.
  • Action
    Smith & Nephew is recommending that surgeons follow standard post-operative follow-up protocols and actions for their patients and ensure that patients are informed about symptoms (particularly pain and knee instability) that might indicate the need for implant review or revision surgery, and the need to seek follow up care should these symptoms arise. For further information please see https://www.tga.gov.au/alert/genesis-ii-knee-system-non-porous-tibial-baseplate-used-knee-replacement. This action has been closed-out on 22/08/2016.

Device

GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate
  • Modèle / numéro de série
    GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate Model Number: 71420182 Batch Number: 14CT39993ARTG Number: 207027
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd