Events

Alerte De Sécurité sur ABGII Modular Femoral Stem and Modular Neck

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Stryker Australia Pty Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-07-23
  • Date de publication de l'événement
    2012-07-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120723.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: stryker australia pty ltd abgii modular femoral stem and modular neck the therapeutic goods administration (tga), australia issued a medical device safety alert concerning abgii modular femoral stem and modular neck manufactured by stryker australia pty ltd. according to the manufacturer, there is potential for fretting and corrosion at the join between the femoral stem and the neck component of the abgii modular system. fretting and corrosion can result in metal debris in and around the hip joint. if this occurs, patients may experience inflammation, adverse local tissue reactions (altrs), hypersensitivity/allergic reactions and osteolysis (bone loss). stryker australia pty ltd has contacted every australian orthopaedic surgeon who has ever implanted the abgii modular hip replacement system. those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. if the results reveal that adverse local tissue reaction of patients are due to metal wear debris, the surgeon should consider proceeding with a revision of the femoral component to a monolithic stem. the manufacturer also advised patients that if experiencing hip or thigh pain, or are concerned about the hip replacement, they should contact their implanting surgeon to arrange a review appointment. for details, please refer to tga website http://www.Tga.Gov.Au/safety/alerts-device-abgii-120720.Htm. posted on 23 july 2012.

Device

ABGII Modular Femoral Stem and Modular Neck
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Stryker Australia Pty Ltd ABGII Modular Femoral Stem and Modular Neck
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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