BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BF GLENOID PEGGED ARTICULAR SURFACE

    MDR report key: 1930685 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01334
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR 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 WAS REPORTED THAT THE PT WAS REVISED DUE TO WEAR. OSTEOLYSIS IS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BF GLENOID PEGGED ARTICULAR SURFACE SHOULDER PROSTHESIS HSD ZIMMER, INC. 60490067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention