Events

Recall of Birmingham Hip Modular Head (BHMH) - Monoblock version

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-2015-RN-01183-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01183-1
  • 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
    A performance review has been conducted of the monoblock birmingham hip modular head (bhmh). based on the analysis of this information, smith & nephew considers that patients implanted with the monoblock bhmh device may be at greater risk of revision surgery.
  • Action
    The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudotumors, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances.

Device

Birmingham Hip Modular Head (BHMH) - Monoblock version
  • Model / Serial
    Birmingham Hip Modular Head (BHMH) - Monoblock versionModel Numbers: 74121238, 74121242, 74121246, 74121250, 74121254, 74121258, 74121338, 74121342, 74121346, 74121350, 74121354, 74121358, 74121438, 74121442, 74121446, 74121450, 74121454, 74121458, 74121538, 74121542, 74121546, 74121550, 74121554 and 74121558All batches affectedThe device has not been available in Australia since 2012.
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd