Events

Safety Alert Or Field Safety Notices for First generation JOURNEY BCS Knee System– Higher than expected risk of revision (MDA/2018/026)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Smith & Nephew.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-07-23
  • Event Date Posted
    2018-07-23
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/first-generation-journey-bcs-knee-system-higher-than-expected-risk-of-revision-mda-2018-026
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    In June 2018, Smith & Nephew issued a Field Safety Notice in relation to the first generation JOURNEY BCS femoral and tibial insert components informing healthcare professionals that the knee system has a higher than expected revision rate. Component loosening has been identified a main cause of device failure.The National Joint Registry of England, Wales and Northern Ireland (NJREWNI) shows the revision rate for the affected device is more than double the average rate for primary total knee replacements. The first generation JOURNEY BCS femoral knee components were phased out globally in 2013-14 and are no longer available for sale.Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.MHRA sought expert clinical advice and recommends all patients should be monitored for signs of device loosening.
  • Reason
    Manufactured by smith & nephew – the device has a higher than expected risk of revision due to early component loosening.
  • Action
    Do not implant affected devices. Locate and return affected devices to Smith & Nephew as detailed in the Field Safety Notice. Monitor patients implanted with affected devices for signs of loosening. Consider annual review for the first 5 years post implantation then every 2 years to 10 years post implantation. Report adverse events involving these devices to your local incident reporting system, the manufacturer, and your national incident reporting authority: England, Scotland, Northern Ireland, Wales.Please note in all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000.

Device

First generation JOURNEY BCS Knee System– Higher than expected risk of revision (MDA/2018/026)
  • Model / Serial
  • Product Description
    All batches of the first generation JOURNEY BCS Knee System are affected. Please refer to the Field Safety Notice for affected Catalogue Numbers.NB: The JOURNEY II BCS Knee system is not subject to this notice.
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew
  • Manufacturer Address
    Smith & Nephew Jason Sells Tel: +1 901-399-5520jason.sells@smith-nephew.com
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    MHRA