Events

Safety Alert for Total Hip Replacement System

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

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
    I1611-533
  • Event Number
    2010DM-0006098
  • Date
    2016-11-25
  • 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 informs about the possibility that fragments of non-ceramic components may remain in the joint after revision surgery, which may lead to premature wear of the components of the system, as a result the instructions for use in relation to the recommended actions in the case of revisions, seeking to avoid the presentation of adverse events on patients.

Device

Total Hip Replacement System
  • Model / Serial
    BIOLOX delta, all lots.
  • Product Description
    The total CORIN hip replacement system is indicated for total hip arthroplasty, using a cementless fixation technique, to provide the patient with increased mobility and reduce pain, replacing the damaged hip joint where there is evidence of enough bone to seat and support the components.It is indicated for non-inflammatory degenerative disease including bone arthritis and non-vascular necrosis, arthritis, rheumatism, correction of functional deformity, non-union treatment, femoral neck and proximal deltrochanter fractures of the femur.
  • Manufacturer
    Corin Limited

Manufacturer

Corin Limited