Events

Alerta De Seguridad O Notificaciones De Seguridad para Birmingham Hip Resurfacing (BHR) 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 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
    MDA/2007/063
  • Número del evento
    CON2032041
  • Fecha
    2007-08-15
  • 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/CON2032041
  • 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 smith & nephew orthopaedics ltd. have been labelled with the wrong cup diameter. the manufacturer recalled some affected products in march 2007 and then extended the recall in june and again in july (see mhra website). the manufacturer has provided mhra with a list of uk affected products (see appendix in pdf only). the mhra is aware of two uk revisions arising from loose fit due to acetabular cups of the wrong diameter being implanted as a result of this mislabelling.
  • Acción
    Identify and quarantine any unimplanted affected devices (see Appendix in pdf only). DO NOT implant affected devices. Return affected devices to the manufacturer. Review the post operative x-rays of patients already implanted with affected devices to identify any 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, reconsider 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

Birmingham Hip Resurfacing (BHR) acetabular cups
  • Modelo / Serial
  • Descripción del producto
    Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd (see Appendix for affected lot numbers in pdf only). BHR acetabular cups (46mm, 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 60mm, 62mm, 64mm). Affected UK lot numbers (see Appendix in pdf only).
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd