BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRAUMA COMPONENT

    MDR report key: 3820021 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00612
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 19, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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 PLATE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289066 UNKNOWN TRAUMA COMPONENT TRAUMA PROSTHESIS HRS ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention