Events

Recall of S&N Journey Bi-Cruciate Stabilised femoral implant

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smith & Nephew Inc.

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
    16001
  • Event Initiated Date
    2014-03-10
  • 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
    The femoral implant/tibial baseplate combination of the journey bcs knee system has been identified in the australian orthopaedic association's national joint replacement registry (aoanjrr) as having a higher than expected revision rate when compared to all other primary total knee replacements.. the aoanjrr data indicates that journey bcs has a higher incidence of revisions due to patellofemoral pain, unspecified pain and instability. the most recent journey bcs knee system revision data published by the njrr include:, - a revision rate of 1.59 (1.34, 1.88) revisions per 100 observed component years compared to 0.72 (0.70, 0.73) for other total knee replacements; and, - a yearly cumulative percent revision of 7.0% (5.8, 8.4) at 5 years compared to 3.8% (3.7, 3.8) for other total knee replacements., smith & nephew is withdrawing the femoral implant component of the journey bcs knee system from the market.
  • Action
    Manufacturer to issue advice regarding use

Device

S&N Journey Bi-Cruciate Stabilised femoral implant

Manufacturer

Smith & Nephew Inc