Events

Alerte De Sécurité sur Birmingham Hip Modular Heads

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

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
    2012-09-25
  • Date de publication de l'événement
    2012-09-25
  • 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_20120925.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: smith and nephew birmingham hip modular heads medical device manufacturer, smith and nephew, has issued a field safety notice concerning birmingham hip modular heads. according to the manufacturer, the average revision rate for the birmingham hip modular head with all stems is currently 1.29 revisions per 100 observed component years in the national joint registry of england and wales and 1.12 revisions per 100 observed component years in the australian orthopaedic association’s national joint replacement registry. these rates exceed the 1% benchmark revision rate established by the uk’s national institute for health and clinical excellence. however, if combined with the uncemented synergy stem, the revision rate is 1.07 revisions per 100 observed years which is acceptable and comparable to other clinically successful hip implants on the market. owing to the above reason, the manufacturer has updated the device’s instructions for use (ifu) (lit. no. 81036947 rev d 03/10 for the application of the birmingham hip modular head). a new stand-alone ifu for the affected product is issued, which includes updates on the contraindications, indications and additional warnings. the sections “information on hydroxyapatite implants” and “information on porous coated implants” that are specific to cups have been removed from the ifu. furthermore, the manufacturer advised users to use the affected product only in accordance with the revised indications for use in the revised ifu. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 25 september 2012.

Device

Birmingham Hip Modular Heads
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smith and Nephew Birmingham Hip Modular Heads
  • Manufacturer
    Smith and Nephew

Manufacturer

Smith and Nephew