Events

Field Safety Notices about Metal on Metal THA systems

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 MicroPort Orthopedics.

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
    2016-07-07
  • 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
    Microport orthopedics has initiated a voluntary field safety corrective action for metal on metal - total hip arthroplasty (tha) indication. implants will be updated with a label which states what part numbers can be used with the conserve cup product and the instructions for use have been revised to remove the metal on metal tha indication. the product will receive the new label and ifu and then distributed. attachment b includes the new ifu. .

Device

Metal on Metal THA systems

Manufacturer

MicroPort Orthopedics