Events

Safety Alert for Trapezometacarpal Prosthesis System MAIA

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

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
    I1612-574
  • Event Number
    2016DM-0014833
  • 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 a problem with labeling indicating size 9 instead of size 10, which leads to instability of the joint in the reduction of the test leading to the occurrence of possible serious adverse events on the patient.

Device

Trapezometacarpal Prosthesis System MAIA
  • Model / Serial
    Metacarpal Stem MAIA 100-0009, lot 2662610.
  • Product Description
    This implant is intended to replace the trapeziometacarpal joint. The main indications are: - advanced articular destruction resulting from a form of rhizarthrosis as a degenerative, post-traumatic, rheumatoid or dysplastic arthritis. -inflammatory injury that includes rheumatoid polyarthritis. -directory review of the dome. -Failure of medical treatment.
  • Manufacturer
    Groupe Lepine

Manufacturer

Groupe Lepine