Events

Rappel de PROFEMUR HIP SYSTEM - NECK VAR/VAL 8DG LONG COBALT CHROME

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MICROPORT ORTHOPEDICS LTD.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19944
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-08-04
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Microport orthopedics inc. is voluntarily recalling profemur long cobalt chrome 8 degree varus/valgus modular neck part number phac1254. this product is used with modular hip stems during total hip arthroplasty surgery. microport orthopedics inc. has received reports of an unexpected rate of postoperative fractures related to this specific part number. all lot numbers may be affected. further distribution or use should cease immediately. there is no evidence fractures can be anticipated by visual inspection or during surgery. when the modular neck fractures the patient may experience sudden pain instability and difficulty walking/performing common tasks. it is expected the patient will recognize immediately that the device is not functioning properly and seek medical attention. a fracture will require revision surgery to remove and replace the neck and stem components.

Device

PROFEMUR HIP SYSTEM - NECK VAR/VAL 8DG LONG COBALT CHROME
  • Modèle / numéro de série
    Model Catalog: PHAC1254 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD