Events

Safety Alert for Trilogy acetabular system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zimmer 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
    R1501-18
  • Event Number
    2011DM-0007492
  • Date
    2015-01-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=188
  • 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 the aforementioned medical devices may present problems due to rupture during insertion, leading to the generation of possible adverse events on the patient or delay of surgical times.

Device

Trilogy acetabular system
  • Model / Serial
    Screws reference 00-6250-065-25 and 00-6250-065-35, specific lots.
  • Product Description
    Indicated as components of a total hip prosthesis in primary or revision patients at high risk of decay dislocation due to a history of anterior dislocation, bone loss, soft tissue laxity, neuromuscular disease, intraoperative stability. To rehabilitate damaged hips as a result of a non-inflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, acetabular protrusio, arthrithopathic, gliding of the epiphysis, melted hip, pelvic fracture, and dystrophic variant.
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA