Events

Safety Alert for Knee System COLUMBUS

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

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
    R1710-519
  • Event Number
    2007DM-0000781
  • Date
    2017-10-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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 confirmed that as part of the continuous improvement of the product, the dimensions of the previous articles have been modified, the modified version of the devices is not compatible with the components of the previous version of the columbus, the joint application of both versions may result a premature loosening of the prosthesis, leading to potential adverse events being presented to patients.

Device

Knee System COLUMBUS
  • Model / Serial
    NR485K, NR486K, NR487K, NR585K, NR586K, NR587K
  • Product Description
    It is used as a component of a human knee endoprosthesis, degenerative osteoarthritis, rheumatoid arthritis, symptomatic instability of the knee and deformity of the knee joint.
  • Manufacturer
    Aesculap Ag

Manufacturer

Aesculap Ag