Safety Alert for Instrumental for Hip Prosthetics LINEAGE and PROFEMUR

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Wright Medical Technology, Inc || Microport Orthopedics 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
    I1612-576
  • Event Number
    2009DM-0003540
  • Date
    2016-12-15
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 states that the two moving surfaces of the articulation are made of metal. there is a growing evidence that the mobile parts of a wear, to the decaying implant (mom) rose against each other, which could generate that seliberen amounts of cobalt (co) and chromium (cr) in the body of the patient, leading to possible serious adverse events on the patient are presented.

Device

  • Model / Serial
    MOM, specific lots.
  • Product Description
    For patients who need a hip replacement. Uses LINEAGE: used to perform femoral stem extraction .. PROFEMUR uses: it is used to scrape the femoral canal and final placement of the implant.
  • Manufacturer

Manufacturer