Events

Rappel de Acor and Integrale primary femoral stem with modular neck

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Amplitude 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-2017-RN-00497-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-09
  • 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-2017-RN-00497-1
  • 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
    Amplitude would like to emphasize that patient selection is a key factor for the primary or revision implantation of the acor and integrale primary femoral stem with modular neck systems. patients with both a large lever arm and a heavy weight often cause severe stress on the modular joint.Reports of femoral neck fractures for certain combinations of modular necks and femoral heads have been received by the manufacturer, amplitude. subsequently, additional mechanical tests determining the fatigue strength of the proximal stem geometry have been conducted on the modular neck stems according to the recent standard iso 7206 -6: 2013 in order to determine which combinations of necks and heads should be subjected to usage restrictions.The surgical technique and the ifu have been updated with these usage restrictions regarding combination bans and admissible patient weight limits.
  • Action
    Neosurgical is updating the IFU and Surgical Technique to highlight to surgeons the importance of observing the head/neck combination restrictions when using the device. Users are also advised to report any adverse reactions observed with the devices to Amplitude and/or to the Therapeutic Goods Administration (TGA).

Device

Acor and Integrale primary femoral stem with modular neck
  • Modèle / numéro de série
    Acor and Integrale primary femoral stem with modular neckReference Numbers: 1-0106701, 1-0106702, 1-0106703, 1-0106704, 1-0191001, 1-0191002, 1-0191003 and 1-0191004Certificate Number: DV-2013-MC-04752-1ARTG Number: 210537
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd