Events

Recall of S&N Birmingham Hip Modular Head, 36mm to 62mm

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
    18345
  • Event Initiated Date
    2015-04-16
  • 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
    In october 2012, smith & nephew issued a hazard alert informing surgeons and hospitals that the birmingham hip™ modular head had 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 late 2014, smith & nephew became aware of new information relating to the performance of bhmh. also, recent registry and clinical data has showed a decline in the performance of the bhmh., based on the analysis of this information, smith & nephew considers that patients implanted with the bhmh device may be at greater risk of revision surgery.
  • Action
    Manufacturer to issue advice regarding use

Device

S&N Birmingham Hip Modular Head, 36mm to 62mm
  • Model / Serial
    Model: Catalogue Numbers: 74222138, 74222140, 74222142, 74222144, 74222146, 74222148, 74222150, 74222152, 74222154, 74222156, 74222158, 74222160, 74222162, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd