Events

Recall of S&N Birmingham Hip Resurfacing (BHR) Acetabular Cup

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smith & Nephew Orthopaedics 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
    18028
  • Event Initiated Date
    2015-02-05
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Reason
    Smith & nephew has updated the instructions for use of the bhr system to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data., if a patient from the following population sub-groups is implanted with a bhr system, the patient is at greater risk of requiring a revision surgery earlier than expected:, * females, * males aged 65 or greater, * patients requiring an implant head size < 48mm, patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarges bursae, pain and swelling local buildup of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function.
  • Action
    Instructions for use to be updated

Device

S&N Birmingham Hip Resurfacing (BHR) Acetabular Cup
  • Model / Serial
    Model: 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122050, 74122152, 74120152, 74120154, 74122154, 74122156, 74120156, 74120158, 74122158, 74122160, 74120160, 74120162, 74122162, 74122164, 74120164, 74120166, 74122166, 74122168, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd