Events

Recall of Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxinium Femoral Component Journey BCS Tibial InsertAll Batch/Lot Numbers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew 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-2018-RN-00859-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00859-1
  • 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
    In january 2014, smith & nephew issued a hazard alert for the journey bcs knee system (tga ref: rc-2014-rn-00004-1) which informed surgeons of the higher than expected revision rate identified by the aoanjrr and advised of the withdrawal of the journey bcs femoral component for primary surgery from the australian market.Smith & nephew is now issuing an update following an analysis of the national joint registry of england, wales & northern ireland (njrewni) & australian orthopaedic association national joint replacement registry (aoanjrr) data on the 1st generation journey bcs knee system.The journey bcs tibial insert remains available for use but should only be used for polyethylene exchange revision of first generation journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.
  • Action
    Surgeons should maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty. Signs and symptoms to consider for potential revisions are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances. Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.

Device

Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxini...
  • Model / Serial
    Journey BCS Knee System - Femoral ComponentsJourney BCS CoCr Femoral ComponentJourney BCS Oxinium Femoral ComponentJourney BCS Tibial InsertAll Batch/Lot NumbersMultiple Catalogue NumbersARTG Number: 278110(Smith & Nephew Pty Ltd - JOURNEY BCS Articular Insert - Prosthesis, internal, joint, knee, tibial component)
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd