Events

Alerta De Seguridad para Trilogy acetabular system

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 Zimmer Inc.

¿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
    R1501-18
  • Número del evento
    2011DM-0007492
  • Fecha
    2015-01-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=188
  • 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 the aforementioned medical devices may present problems due to rupture during insertion, leading to the generation of possible adverse events on the patient or delay of surgical times.

Device

Trilogy acetabular system
  • Modelo / Serial
    Screws reference 00-6250-065-25 and 00-6250-065-35, specific lots.
  • Descripción del producto
    Indicated as components of a total hip prosthesis in primary or revision patients at high risk of decay dislocation due to a history of anterior dislocation, bone loss, soft tissue laxity, neuromuscular disease, intraoperative stability. To rehabilitate damaged hips as a result of a non-inflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, acetabular protrusio, arthrithopathic, gliding of the epiphysis, melted hip, pelvic fracture, and dystrophic variant.
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA