BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL WITHOUT HOLES

    MDR report key: 3242947 · Received July 19, 2013

    Report

    Report Number
    1822565-2013-01122
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 LOOSENING AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337993 TRILOGY SHELL WITHOUT HOLES MEH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CATALOG #00630505828, LOT #UNK| TRILOGY LONGEVITY POLY LINER,