Events

Alerta De Seguridad O Notificaciones De Seguridad para DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation

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 manufacturer #17429.

¿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/2007/054
  • Número del evento
    CON2031467
  • Fecha
    2007-06-14
  • 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/CON2031467
  • 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
    Unexplained groin pain. the need for early revision due to periprosthetic soft tissue necrosis. the ultima tps femoral stem and ultima metal-on-metal articulation (femoral head plus metal acetabular cup) is a total hip replacement system that has been on the market in the uk since 1997. the ultima tps femoral stem is still available but the ultima metal-on-metal femoral head and acetabular cup were discontinued in 2005. up to april 2007, one uk study has reported 43 revisions (from a cohort of 637 hips) associated with extensive periprosthetic soft tissue necrosis. some also involved late dislocation or periprosthetic fracture. the revisions were required one to seven years after implantation. there have been no other confirmed reports. when these stems were explanted, extensive corrosion was observed on the surface of many of them within the area of the cement mantle. this level of corrosion of cemented polished cobalt chromium molybdenum stems has not previously been reported in the orthopaedic literature and the explanation for it is unclear. depuy has already communicated this information to uk hospitals that implanted these devices. a copy of their letter, including recommendations for imaging and patient management, is in the appendix.
  • Acción
    Refer patients with this implant combination who present with unexplained groin pain for MRI scan. This is in line with the parameters recommended by DePuy (see recommendations for patient management under ‘Action’ in the appendix). Patients with abnormal signs should be considered for an early revision. Report all revisions of metal-on-metal articulations where corrosion and/or periprosthetic soft tissue reaction are observed to the implant manufacturer and the MHRA.

Device

DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation
  • Modelo / Serial
  • Descripción del producto
    Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. These components were only sold in combination in the UK, France and Italy.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429