Events

Safety Alert for Prosthesis System for Articular Replacements

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

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
    R1709-459
  • Event Number
    2014DM-0011287
  • Date
    2017-09-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • 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

Device

Prosthesis System for Articular Replacements
  • Model / Serial
    IMP74115, lot 012154004000
  • Product Description
    The prosthesis system for joint replacements and its associated instruments C2F is designed for the partial or total artificial replacement of the joints of the body and indicated for the treatment of joint complexes, osteoarthritis, joint instabilities. Allowing to restore mobility, correct joint deformities, joint reconstruction, with specific clinical indications according to articulation and reference. Prostheses for hip replacement of the prosthesis system for joint replacements and their associated instruments C2F, have other indications:? In case of pain due to the articulated joint destruction resulting from degenerative, inflammatory or post-traumatic pathology, or to the resulting effects after a trauma, or to the failure of previous operations. ? For first or secondintention surgery. ? Avascular necrosis. ? Traumatic arthritis ? Degenerative inflammatory disease of the joints including rheumatoid arthritis, arthritis secondary to a variety of diseases and abnormalities, and congenital dysplasia among other indications for use, prostheses for knee replacement of the prosthesis system for joint replacements and its associated instruments c2f®, for the treatment of:? Rheumatoid arthritis ? Post-traumatic arthritis, laosteoarthritis or degenerative arthritis. ? Failed osteotomies? Advanced articular destruction resulting from degenerative, inflammatory opost-traumatic pathology? Surgery of first intention, in the primary gonarthrosis associated to: important axial deviation, important laxity or important rigidity. ? Revision surgery of knee prostheses that have been found, in particular, in the case of a second recurrence of axial deviation, abnormal laxity or severe rigidity.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA