Events

Alerta De Seguridad para Total Shoulder Prosthesis ARROW

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por F.H. Industrie.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1712-569
  • Número del evento
    2009DM-0005022
  • Fecha
    2017-12-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=62
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that after three fractures of the morsereferenced cone in the affected implants, which occurred before implementing the 2013 improvements, the decision was made to recover these implants as a precautionary measure, the situation described leads to possible delays in the procedures. or adverse events about patients.

Device

Total Shoulder Prosthesis ARROW
  • Modelo / Serial
    Concerning the morse cone of the humeral insert references 257057
  • Descripción del producto
    Total shoulder arthroplasty is indicated under the following conditions: a very painful and / or incapacitated joint caused by osteoarthritis, traumatic arthritis, rheumatic arthritis; avascular necrosis of the humeral head; acute traumatic fracture of the head or neck; Previous unsuccessful surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, replacement replacement arthroplasty, or total shoulder replacement.
  • Manufacturer
    F.H. Industrie

Manufacturer

F.H. Industrie
  • Source
    NIDFSINVIMA