Events

Recall of Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical Pty Ltd.

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
    RC-2012-RN-00988-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00988-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The birmingham hiptm modular head (bhmh) as part of a total conventional hip replacement system has been identified in the australian national joint replacement registry (njrr) and the national joint registry of england and wales (njrew) as having a higher than expected revision rate when compared to all other total conventional hip replacements. in addition, most of the revisions that are occurring later (after the third year) are linked to metal sensitivity and infection.
  • Action
    Smith & Nephew is advising implanting/treating surgeons on how to manage patients implanted with the Birmingham Hip Modular Heads. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-bhmh-121030.htm

Device

Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)
  • Model / Serial
    Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)Part Numbers : 121238 – 121258, 121338 – 121558, 74121238 – 74121558 & 74222138 – 74222162 All Batches ARTG Number: 124100
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd