Events

Alerta De Seguridad O Notificaciones De Seguridad para Adept acetabular cups

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 Finsbury Orthopaedics.

¿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
    MDA/2007/067
  • Número del evento
    CON2032218
  • Fecha
    2007-08-29
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032218
  • 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
    Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups. the need for early revision due to loose joint fit as a result of mislabelled cups. some acetabular cups manufactured by finsbury orthopaedics have been labelled with the wrong cup diameter. the manufacturer recalled affected products in august 2007 (see mhra website for field safety notice). the manufacturer has provided mhra with a list of uk affected products (see appendix). affected products were distributed to uk hospitals between 17/11/2006 and 19/02/2007.
  • Acción
    Identify and quarantine any unimplanted affected devices (see appendix). DO NOT implant affected devices. Return affected devices to the manufacturer. Review the post operative X-rays of these patients to identify size mismatch of head and cup. In patients with mismatched devices: consider the need for implant revision where implants are not being revised, consider measuring serial serum cobalt and chromium levels to monitor implant wear over time if monitoring reveals these levels are increasing, re-consider the need for implant revision. Set up systems to report all revisions with these incorrectly labelled cups to the implant manufacturer and the MHRA.

Device

Adept acetabular cups
  • Modelo / Serial
  • Descripción del producto
    Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes). Adept acetabular cups (48mm and 52mm). Affected UK lot codes (see appendix).
  • Manufacturer
    Finsbury Orthopaedics

Manufacturer

Finsbury Orthopaedics