Events

Safety Alert Or Field Safety Notices for VKS, RT-Plus and TC-Plus femoral and tibial knee components

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 Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd.

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
  • Event ID
    MDA/2008/003
  • Event Number
    CON2033730
  • Date
    2008-01-16
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2033730
  • 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
  • Reason
    Extension of recall of implants which may have incorrect alloy composition. as a result of a manufacturing error, some knee implant components have been made from an alloy of incorrect composition. in november 2007, the manufacturer recalled some affected products and provided the mhra with a list of uk affected products (see appendix (in pdf only) - rows in grey). the mhra issued mda/2007/092 relating to this recall, on 4 december 2007. the manufacturer extended the recall in december 2007 (see appendix (in pdf only) for full list of uk affected products). 520 affected products have been distributed to uk hospitals since june 2007. the clinical implications for patients implanted with affected products are currently being assessed. the manufacturer’s initial risk assessment is that there is no indication of any health risk to patients as a result of the higher iron content in these devices. the manufacturer is, however, carrying out further tests in order to fully assess the situation. the mhra will issue further advice on patient management when this assessment has been completed.
  • Action
    Do not implant affected products (lot numbers listed in Appendix). Quarantine all affected products and return them to the manufacturer. Report revisions or adverse incidents related to affected products to the MHRA.

Device

VKS, RT-Plus and TC-Plus femoral and tibial knee components
  • Model / Serial
  • Product Description
    Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers).
  • Manufacturer
    Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd

Manufacturer

Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd