Events

Rappel de LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia 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-01191-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-19
  • 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-01191-1
  • 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
    Stryker has identified a non-conformance due to a trend analysis showing an incidence of taper lock failures higher than the predicted rate (>0.05%) for four lfit anatomic cocr v40 femoral heads manufactured prior to 2011. the increased incidence of taper lock failures relates to possible taper lock interface inconsistency. potential hazards include disassociation of femoral head from hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of motion, insufficient soft tissue tension, noise, loss of implant, bone fixation strength, increased wear debris (polymeric), implant construct with a shortened neck length.
  • Action
    Stryker is advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40TM Femoral Heads should continue to be followed per the normal protocol established by his/her surgeon.

Device

LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)
  • Modèle / numéro de série
    LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)Item: 6260-9-236Head diameter 36mm; Offset +5Item: 6260-9-240Head diameter 40mm; Offset +4Item: 6260-9-244Head diameter 44mm; Offset +4Item: 6260-9-340Head diameter 40mm; Offset +8Item: 6260-9-440Head diameter 40mm; Offset +12Item: 6260-9-344Head diameter 44mm; Offset +8Item: 6260-9-444Head diameter 44mm; Offset +12Multiple lot numbers affected ARTG #: 211868
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA