BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL GLENOSPHERE

    MDR report key: 1924380 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01287
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR A DISENGAGED MORSE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL GLENOSPHERE SHOULDER PROSTHESIS HSD ZIMMER, INC. 61461367

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention