Events

Alerte De Sécurité sur Limb Preservation System Diaphyseal Sleeve

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 Orthopaedic Inc.

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
    2013-02-25
  • Date de publication de l'événement
    2013-02-25
  • 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_20130225.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 limb preservation system diaphyseal sleeve the united states food and drug administration (fda) has issued a medical device safety alert concerning limb preservation system (lps) diaphyseal sleeve manufactured by depuy orthopaedic inc. the affected devices were manufactured and distributed from 2008 to 20 july 2012. all lot numbers with product codes 1987-20-018, 1987-20-020, 1987-20-024 and 1987-20-028 are affected. according to the manufacturer, the lps diaphyseal sleeve to diaphyseal sleeve base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. this may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death. the fda has received a total of 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned. depuy advised the affected customers to immediately stop distributing or using the recalled lots. depuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device. however, depuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms. the local supplier, johnson & johnson (hong kong) ltd., confirmed that the affected product has not been marketed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm340708.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 february 2013.

Device

Limb Preservation System Diaphyseal Sleeve
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Limb Preservation System Diaphyseal Sleeve
  • Manufacturer
    DePuy Orthopaedic Inc

Manufacturer

DePuy Orthopaedic Inc