Events

Rappel de MSA Hip SystemMSA Neutral Femoral 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 Global Manufacturing Technology 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-2014-RN-00685-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-30
  • 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-2014-RN-00685-1
  • 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
    The 2013 annual report of the national joint replacement registry (njrr) indicates that up to december 2012, the cumulative percent revision of the msa hip system has been calculated as 6.2 % at one year and approximately 11% at 2 years , both of which are significantly higher than that of other hip replacement prostheses. the most common reasons for revision of msa to date have been loosening/lysis and peri-prosthetic fracture, but there have also been a few revisions due to prosthesis dislocation, pain and infection.After consultation with the therapeutic goods administration, a decision has been made by global orthopaedic technology to cease supply of the msa hip stem. this device has been removed from the australian register of therapeutic goods.
  • Action
    Global Orthopaedic Technology is informing implanting surgeons that it is advisable for annual clinical and radiological examinations to be performed on patients who have been implanted with this device, in accordance with routine patient post arthroplasty care. For more details, please see http://tga.gov.au/safety/alerts-device-msa-hip-system-140703.htm .

Device

MSA Hip SystemMSA Neutral Femoral Neck
  • Modèle / numéro de série
    MSA Hip SystemMSA Neutral Femoral Neck Catalogue number range: GH-220-00 to GH-260-08MSA Ante-Retro-Version Femoral Neck Catalogue number range: GH-221-00 to GH-261-00MSA Titanium HA Custom Femoral Stem Catalogue number range: GH-1400-00 to GH-14000-25ARTG Number: 120787
  • Manufacturer
    Global Manufacturing Technology Pty Ltd

Manufacturer

Global Manufacturing Technology Pty Ltd