Events

Safety Alert for Total Knee Prosthesis ADVANCE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by 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
    I1611-538
  • Event Number
    2013DM-0001668-R1
  • Date
    2016-11-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=112
  • 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 implant is experiencing higher than expected revision rates, where a large proportion corresponds to loosening that leads to explantations, which could lead to potential adverse events on the patients.

Device

Total Knee Prosthesis ADVANCE
  • Model / Serial
    ADVANCE HA - KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, || KTTIHA50, KTTIHA51 and KTTIHA60.
  • Product Classification
    Orthopedic Devices
  • Product Description
    Total WRIGHT knee systems are indicated for use in knee arthroplasty in patients with skeletal maturity and the following conditions; 1) non-inflammatory degenerative joint disease, including arthritis, traumatic arthritis or avascular necrosis; inflammatory degenerative disease, including rheumatoid arthritis; correction of deformities functions; review procedures when other treatments or devices have failed; and treatment of fractures that can not be controlled.
  • Manufacturer
    Microport Orthopedics Inc.

Manufacturer

Microport Orthopedics Inc.