BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METGLNE SCRW DIA 4.5X36MM SPH

    MDR report key: 731555 · Received June 30, 2006

    Report

    Report Number
    1818910-2006-01889
    Event Type
    Injury
    Date Received
    June 30, 2006
    Date of Event
    June 6, 2006
    Report Date
    June 6, 2006
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO LOOSENING OF THE GLENOSPHERE AND METAGLENE. REPORT STATES THAT ONE OF HTE SCREWS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METGLNE SCRW DIA 4.5X36MM SPH TOTAL FIXATION DEVICE HWC DEPUY FRANCE S.A. NA 1823587

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention