Events

Recall of BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing Head

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-00493-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00493-1
  • 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
    Smith & nephew (s&n;) has conducted an analysis of recent national joint registry of england and wales data. the data indicate that 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 .S&n; is informing customers that: - the use of bhr in female patients is to be contraindicated;- bhr femoral head components sized 46mm in diameter and smaller, and their corresponding acetabular cup sizes, are no longer to be used and are to be returned to s&n; and- patients requiring a 48mm femoral head size are at a moderately elevated risk of revision and should not be considered as candidates for bhr implantation.
  • Action
    Surgeons are advised that 48mm heads should only be used in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery. Surgeons are recommended to maintain their routine follow-up protocol for patients who have undergone hip resurfacing arthroplasty. Patients who experience symptoms including limited mobility, 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. This action has beem closed-out on 31/08/2016.

Device

BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing Head
  • Model / Serial
    BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing HeadCatalogue Numbers: 74121138, 74123140, 74121142, 74123144, 74121146BHR Acetabular CupCatalogue Numbers: 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122150, 74122152, 74120152, 74120154BHR Dysplasia CupCatalogue Numbers: 74120246, 74122248, 74120250, 74122252, 74120254ARTG numbers: 120078 & 124099
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd