BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 3893663 · Received June 10, 2014

    Report

    Report Number
    2648920-2014-00150
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN. DURING REVISION, SURGEON FOUND NECROTIC TISSUE AND REPLACED THE LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340307 VERSYS FEMORAL HEAD JDI ZIMMER 61860433

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention TRILOGY LONGEVITY CROSSLINKED POLY LINER:| CATALOG # 00630505036, LOT # 61944273