Events

Alerta De Seguridad para Nexgen knee solution

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
    R1407-291
  • Número del evento
    2011DM-0007278
  • Fecha
    2014-07-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=200
  • 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 informs that it has detected that it is possible that the clamping threads do not conform to the specifications, leading to the generation of possible adverse events on the patient.

Device

Nexgen knee solution
  • Modelo / Serial
    5950 with specific lots distributed between February 26, 2010 and May 15, 2014
  • Descripción del producto
    This device is indicated for patients with severe knee pain and disability due to: • rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Deogenous disorders, and / or vascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is a patellofemoral erosion, dysfunction or previous patellectomy. • Moderate deformitiesvalue, varus or flexion. • The rescue of unsuccessful surgical attempts previously or for knee in which satisfactory stability can be obtained at the time of surgery.
  • 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