Events

Recall of BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22587
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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)
  • Product Description
    BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.