Events

Safety Alert for Prosthesis for Hip Replacement

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Tornier, Inc.

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
    I1612-573
  • Event Number
    2012DM-0009126
  • Date
    2016-12-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=109
  • 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 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
  • Model / Serial
  • Product Description
    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