Events

Alerta De Seguridad para Total Hip Replacement 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 Corin Limited.

¿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
    I1611-533
  • Número del evento
    2010DM-0006098
  • Fecha
    2016-11-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=112
  • 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 about the possibility that fragments of non-ceramic components may remain in the joint after revision surgery, which may lead to premature wear of the components of the system, as a result the instructions for use in relation to the recommended actions in the case of revisions, seeking to avoid the presentation of adverse events on patients.

Device

Total Hip Replacement System
  • Modelo / Serial
    BIOLOX delta, all lots.
  • Descripción del producto
    The total CORIN hip replacement system is indicated for total hip arthroplasty, using a cementless fixation technique, to provide the patient with increased mobility and reduce pain, replacing the damaged hip joint where there is evidence of enough bone to seat and support the components.It is indicated for non-inflammatory degenerative disease including bone arthritis and non-vascular necrosis, arthritis, rheumatism, correction of functional deformity, non-union treatment, femoral neck and proximal deltrochanter fractures of the femur.
  • Manufacturer
    Corin Limited

Manufacturer

Corin Limited