Events

Safety Alert for Prosthesis for Joint Replacement

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Mdt Indústria Comércio Importação E Exportação De Implantes S.A. || Biotechnology Ortopedia Importacao E Exportacao Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1703-96
  • Event Number
    2014DM-0002401-R1
  • Date
    2017-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    The manufacturer has determined that in the referenced devices there is a possible deviation of the measures according to the technical specifications, leading to the occurrence of possible adverse events on the patient or delays in the procedure.

Device

Prosthesis for Joint Replacement
  • Model / Serial
  • Product Description
    The MDT / BIOTECHNOLOGY joint replacement prostheses are indicated for joint, shoulder, knee and hip joint replacement procedures, whether total, partial, modular or revision. Their purpose is to replace bone and joint stabilization components for the reconstruction of joint function in patients with joint injuries as a result of pathologies, among others: non-inflammatory degenerative joint disease (osteoarthritis), avascular necrosis, osteoarthritis secondary to trauma, -sequences of trauma, -anquilosis-surgical arthrodesis.
  • Manufacturer
    Mdt Indústria Comércio Importação E Exportação De Implantes S.A. || Biotechnology Ortopedia Importacao E Exportacao Ltda

Manufacturer

Mdt Indústria Comércio Importação E Exportação De Implantes S.A. || Biotechnology Ortopedia Impor...
  • Source
    NIDFSINVIMA