Events

Retiro De Equipo (Recall) de BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITH & NEPHEW INC..

¿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
    22587
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-06-05
  • 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
    As part of its post market surveillance (pms) and post-marketing clinical follow-up processes smith & nephew has conducted an analysis of recent national joint registry of england and wales (njrew) data (the largest arthroplasty registry cohort of bhr patients). a health hazard evaluation (hhe) was conducted to review this analysis. the data indicate that the bhr system continues to perform well in the male population requiring femoral head components 50mm in diameter and larger. however the revision rates associated with the female gender and smaller femoral head sizes regardless of gender perform less well and exceed the current revision rate benchmark established by the uk national institute for health and care excellence (nice).

Device

BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS
  • Modelo / Serial
    Model Catalog: 74120144 (Lot serial: ALL); Model Catalog: 74121146 (Lot serial: ALL); Model Catalog: 74123144 (Lot serial: ALL); Model Catalog: 74121142 (Lot serial: ALL); Model Catalog: 74123140 (Lot serial: ALL); Model Catalog: 74121138 (Lot serial: ALL); Model Catalog: 74120254 (Lot serial: ALL); Model Catalog: 74122252 (Lot serial: ALL); Model Catalog: 74120250 (Lot serial: ALL); Model Catalog: 74122248 (Lot serial: ALL); Model Catalog: 74120146 (Lot serial: ALL); Model Catalog: 74122146 (Lot serial: ALL); Model Catalog: 74122148 (Lot serial: ALL); Model Catalog: 74120148 (Lot serial: ALL); Model Catalog: 74120150 (Lot serial: ALL); Model Catalog: 74122150 (Lot serial: ALL); Model Catalog: 74122152 (Lot serial: ALL); Model Catalog: 74120246 (Lot serial: ALL); Model Catalog: 74120154 (Lot serial: ALL); Model Catalog: 74120152 (Lot serial: ALL)
  • Descripción del producto
    BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    HC