Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Advanced Surgical Design and Manufacture.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 050 12 12 000
  • Fecha de inicio del evento
    2012-12-09
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2713
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Asdm is aware of elevated failure rates of the patella component of the active knee system, specifically related to the shearing of the pegs. electron microscopy of the failed patella has shown that the pegs are failing due to fatigue. the initiation site for the fatigue failure point appears to be a small overhang artefact, between 10 to 30 microns in depth, at the base of the patella peg. this small artefact may lead to elevated stresses at the base of the peg, and therefore increase the probability of premature product failure.

Device

Prosthesis, internal, joint, knee, total - Patella, Active Knee – Patella component
  • Modelo / Serial
    ARTG Number (ASDM Part Number, Lots Affected): 133900 (10-1514-075X, Lots manufactured prior to June 2012)
  • Descripción del producto
    Prosthesis, internal, joint, knee, total - Patella
  • Manufacturer
    Advanced Surgical Design and Manufacture

Manufacturer

Advanced Surgical Design and Manufacture