Events

Field Safety Notices about SIGMA® HP PFJ Cemented trochlear implants for use in knee surgery

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 DePuy Orthopaedics, Inc..

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
  • 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
    At depuy orthopedics, inc., we have decided to voluntarily recall the sigma® hp pfj cemented trichlear implants product, which is an independent component of the partial knee system (see figure 1). the decision is due to the increased volume of audits we have detected in our post-market surveillance process. we will immediately cease further distribution and use of the defective product whose production is stopped. the company recommends that surgeons use alternative implants or opt for a complete knee replacement.

Device

SIGMA® HP PFJ Cemented trochlear implants for use in knee surgery

Manufacturer

DePuy Orthopaedics, Inc.