Events

Safety Alert for MoPyC Radial Head Prosthesis Stem

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Tornier.

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
  • Date
    2015-10-14
  • Event Date Posted
    2015-10-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151014.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: tornier mopyc radial head prosthesis stem medical device manufacturer, tornier, has issued a field safety notice regarding the radial head prosthesis – mopyc stem – small (catalog number ptr-s7). according to the manufacturer, there is a known risk potentially associated with over-expansion of the affected product that can result in its postoperative fatigue fracture. although the operating technique emphasizes the fact that stem expansion should only be performed when rotation instability is observed in the shaft, the manufacturer noticed that the stems which were subject to fracture were over-expanded. therefore, the manufacturer decided to provide users with a surgical technique addendum (ucmt153) to emphasize this key point of the operating technique and avoid unnecessary stem expansion that may be harmful to the patient. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 october 2015.

Device

MoPyC Radial Head Prosthesis Stem
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Tornier

Manufacturer

Tornier