Alerta De Seguridad O Notificaciones De Seguridad para VKS, RT-Plus and TC-Plus femoral and tibial knee components

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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.


  • Modelo / Serial
  • Descripción del producto
    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