Events

Alerta De Seguridad para Total Knee Prosthesis ADVANCE

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 Microport Orthopedics 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
    I1611-538
  • Número del evento
    2013DM-0001668-R1
  • Fecha
    2016-11-28
  • 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 reports that it has detected that the implant is experiencing higher than expected revision rates, where a large proportion corresponds to loosening that leads to explantations, which could lead to potential adverse events on the patients.

Device

Total Knee Prosthesis ADVANCE
  • Modelo / Serial
    ADVANCE HA - KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, || KTTIHA50, KTTIHA51 and KTTIHA60.
  • Clasificación del producto
    Orthopedic Devices
  • Descripción del producto
    Total WRIGHT knee systems are indicated for use in knee arthroplasty in patients with skeletal maturity and the following conditions; 1) non-inflammatory degenerative joint disease, including arthritis, traumatic arthritis or avascular necrosis; inflammatory degenerative disease, including rheumatoid arthritis; correction of deformities functions; review procedures when other treatments or devices have failed; and treatment of fractures that can not be controlled.
  • Manufacturer
    Microport Orthopedics Inc.

Manufacturer

Microport Orthopedics Inc.