Events

Alerte De Sécurité sur DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants

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.

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
    2017-09-15
  • Date de publication de l'événement
    2017-09-15
  • 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_20170915b.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 delta xtend reverse shoulder system modular centered and eccentric epiphysis implants medical device manufacturer, depuy, has issued a medical device safety alert concerning its delta xtend reverse shoulder system modular centered and eccentric epiphysis implants. the affected devices are identified as the following:- part description: i) modular centered epiphysis size 1 ha; ii) modular eccentric epiphysis size 1 left ha part numbers: i) 130720101; ii) 130720102 lot numbers: i) 5281492 and 5276801; ii) 5289608 and 5280184 the manufacturer’s investigation determined that the affected lots produced in a specific machine were manufactured in a manner in which the post’s diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) may not be able to be assembled. according to the manufacturer, there are two potential instances in which the patient could be affected: if the epiphysis does not assemble to the stem and an alternative device is available, there may be a surgical delay of 15 to 59 minutes. if the epiphysis does not assemble to the stem and there is not an alternative implant available, the patient’s wound may need to be closed and the patient scheduled for a reoperation when a suitable device is available. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 september 2017.

Device

DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants
  • Manufacturer
    DePuy

Manufacturer

DePuy