Events

Safety Alert for Total Shoulder Prosthesis ARROW

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

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
    R1712-569
  • Event Number
    2009DM-0005022
  • Date
    2017-12-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=62
  • 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 after three fractures of the morsereferenced cone in the affected implants, which occurred before implementing the 2013 improvements, the decision was made to recover these implants as a precautionary measure, the situation described leads to possible delays in the procedures. or adverse events about patients.

Device

Total Shoulder Prosthesis ARROW
  • Model / Serial
    Concerning the morse cone of the humeral insert references 257057
  • Product Description
    Total shoulder arthroplasty is indicated under the following conditions: a very painful and / or incapacitated joint caused by osteoarthritis, traumatic arthritis, rheumatic arthritis; avascular necrosis of the humeral head; acute traumatic fracture of the head or neck; Previous unsuccessful surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, replacement replacement arthroplasty, or total shoulder replacement.
  • Manufacturer
    F.H. Industrie

Manufacturer

F.H. Industrie
  • Source
    NIDFSINVIMA