Events

Safety Alert for Radial Head Prosthesis System

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

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
    2017-01-10
  • Event Date Posted
    2017-01-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170110c.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: depuy synthes radial head prosthesis system medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning the removal of its radial head prosthesis system. the entire depuy synthes radial head prosthesis system is affected by this removal, however it is the radial stem that has the possibility of loosening post-operatively at the stem bone interface. based on the currently available data, the manufacturer believes the cause to be multifactorial (including possible product characteristics, operative and patient factors), but they have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and has decided to remove the depuy synthes radial head prosthesis stem from the global market. health care practitioners that have treated patients using the affected products should continue to follow those patients in the usual manner. according to the manufacturer, if the radial stern becomes loose post-operatively, the following may occur: device loosening, osteolysis, poor joint mechanics, pain, bone fracture - post-operatively, and soft tissue damage (soft tissue irritation). the manufacturer is requesting users to immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. the affected products should be returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 january 2017.

Device

Radial Head Prosthesis System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DePuy Synthes Radial Head Prosthesis System
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes