BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HUMERAL PLATE

    MDR report key: 2980530 · Received February 21, 2013

    Report

    Report Number
    1822565-2013-00360
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 PATIENT WAS REVISED DUE TO THE SCREWS BACKING OUT OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75088 UNKNOWN ZIMMER HUMERAL PLATE TRAUMA PROSTHESIS HRS ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN ZIMMER SCREWS| CATALOG #UNK, LOT #UNK