Events

Field Safety Notices about Radial Head Prosthesis System

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Synthes GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-12-30
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The entire depuy synthes radial head prosthesis system is affected by this removal, however it is the radial stern that has the possibility of loosening post—operatively at the stem bone interface based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors. consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the depuy synthes radial head prosthesis stem from the global market.

Device

Radial Head Prosthesis System

Manufacturer

Synthes GmbH