Events

Safety Alert for Instrument for revision surgeries of hip and knee implants

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Peter Brehm Gmbh Chirurgie- Mechanik.

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
    R1603-107
  • Event Number
    2009DM-0004696
  • Date
    2016-03-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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 it has detected that the referenced devices manufactured in the period from june 2013 to february 2015, may have been manufactured under a modified manufacturing process, leading to potential adverse events on patients or delays in surgical procedures.

Device

Instrument for revision surgeries of hip and knee implants
  • Model / Serial
    Concerning the guide (Guiding Rod), reference 60900-66-2, specific serials.
  • Product Description
    Instrumental to assist in hip replacement surgeries and knee replacements.
  • Manufacturer
    Peter Brehm Gmbh Chirurgie- Mechanik

Manufacturer

Peter Brehm Gmbh Chirurgie- Mechanik