BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD HYL PEG GLENOID 44

    MDR report key: 232748 · Received July 23, 1999

    Report

    Report Number
    1818910-1999-00099
    Event Type
    Injury
    Date Received
    July 23, 1999
    Date of Event
    May 5, 1999
    Report Date
    July 20, 1999
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT CLAIMS THAT THE GLENOID COMPONENT FRAGMENTED. SURGEON NOTED"THE SMALLER HEAD THAN THE COLLAR WAS THE WRONG CHOICE FOR A TIGHT SHOULDER". ON SET OF SYMPTOMS WERE 010-02-1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD HYL PEG GLENOID 44 Implant TOTAL SHOULDER PROSTHESIS KWS DEPUY ORTHOPAEDICS, INC. NA 743460004

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention