Events

Alerte De Sécurité sur Apex K2 Femoral Stem

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

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
    2012-11-01
  • Date de publication de l'événement
    2012-11-01
  • 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_20121101a.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: omnilife science apex k2 femoral stem the therapeutic goods administration (tga), australia issued a medical device alert concerning apex k2 femoral stem, manufactured by omnilife science, inc. (global orthopaedic technology as the sponsor in australia) the tga advised health professionals and patients that global orthopaedic technology has cancelled the apex k2 femoral stem from the australian register of therapeutic goods. the decision to cancel was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the apex k2 femoral stem had a higher than expected revision rate. the 2012 australian njrr report indicated that the cumulative revision rate for the apex k2 modular hip replacement system was 5.5% at 1 year from the time of implantation and 9.3% at 3 years. a headline revision rate of 4.6 revisions per 100 observed years compared to 1.6% at 1 year and 2.8 % at 3 years from implantation and a headline revision rate of 0.81 revisions per 100 observed years for all other total conventional hip replacements. for details, please visit the following tga website: http://www.Tga.Gov.Au/safety/alerts-device-hip-apex-k2-121030.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

Apex K2 Femoral Stem
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: OMNILife science Apex K2 Femoral Stem
  • Manufacturer
    OMNILife science

Manufacturer

OMNILife science