Events

Alerte De Sécurité sur Radial Head Prosthesis System

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

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
    2017-01-10
  • Date de publication de l'événement
    2017-01-10
  • 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_20170110c.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: depuy synthes radial head prosthesis system medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning the removal of its radial head prosthesis system. the entire depuy synthes radial head prosthesis system is affected by this removal, however it is the radial stem that has the possibility of loosening post-operatively at the stem bone interface. based on the currently available data, the manufacturer believes the cause to be multifactorial (including possible product characteristics, operative and patient factors), but they have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and has decided to remove the depuy synthes radial head prosthesis stem from the global market. health care practitioners that have treated patients using the affected products should continue to follow those patients in the usual manner. according to the manufacturer, if the radial stern becomes loose post-operatively, the following may occur: device loosening, osteolysis, poor joint mechanics, pain, bone fracture - post-operatively, and soft tissue damage (soft tissue irritation). the manufacturer is requesting users to immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. the affected products should be returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 january 2017.

Device

Radial Head Prosthesis System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Synthes Radial Head Prosthesis System
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes