Events

Retiro De Equipo (Recall) de PROFEMUR HIP SYSTEM - NECK VAR/VAL 8DG LONG COBALT CHROME

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MICROPORT ORTHOPEDICS LTD.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    19944
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-08-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    Model Catalog: PHAC1254 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    PROFEMUR Neck VAR/VAL 8DG Long Cobalt Chrome Neck
  • Manufacturer
    MICROPORT ORTHOPEDICS LTD

Manufacturer

MICROPORT ORTHOPEDICS LTD