Events

Alerte De Sécurité sur MoPyC Radial Head Prosthesis 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 Tornier.

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
    2015-10-14
  • Date de publication de l'événement
    2015-10-14
  • 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_20151014.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: tornier mopyc radial head prosthesis stem medical device manufacturer, tornier, has issued a field safety notice regarding the radial head prosthesis – mopyc stem – small (catalog number ptr-s7). according to the manufacturer, there is a known risk potentially associated with over-expansion of the affected product that can result in its postoperative fatigue fracture. although the operating technique emphasizes the fact that stem expansion should only be performed when rotation instability is observed in the shaft, the manufacturer noticed that the stems which were subject to fracture were over-expanded. therefore, the manufacturer decided to provide users with a surgical technique addendum (ucmt153) to emphasize this key point of the operating technique and avoid unnecessary stem expansion that may be harmful to the patient. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 october 2015.

Device

MoPyC Radial Head Prosthesis Stem
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Tornier

Manufacturer

Tornier