Events

Alerta De Seguridad para Prosthesis for Hip Replacement

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 Tornier, 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
    I1612-573
  • Número del evento
    2012DM-0009126
  • Fecha
    2016-12-14
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=109
  • 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 in compliance with iso72096-4 version2010, the compliance criteria for testing and fatigue behavior of the resistance properties of the neck region of the femoral stem component of the hip prostheses were performed on the the base of an extra-long neck is applied to all stem configurations, including those that are referenced. therefore, the emphasis is on reviewing this information in order to determine the suitability of the implanted prosthesis, so that no serious adverse events may occur. .

Device

Prosthesis for Hip Replacement
  • Modelo / Serial
  • Descripción del producto
    Preset prostheses for hip joint replacement or revision. Its main function is to reduce pain and restore the function of the hip joint, compared with preoperative readiness. They are indicated for primary replacement of hip joints in: degenerative pathologies, patients with high risk of dislocation, necrosis of the femoral head, fracture of the femoral neck, congenital dislocation. For secondary replacement of the hip joint: in cases of substantial bone loss, in which forced adjustment is not sufficient to ensure elimination and for patients at high risk of recurrent dislocation.
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc