BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULNAR RIGHT 60MM STANDARD

    MDR report key: 1210595 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-04821
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDC
    PMA / PMN Number
    K992656
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF LOOSENING OF THE ULNAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULNAR RIGHT 60MM STANDARD 87JDC JDC DEPUY ORTHOPAEDICS, INC. NA XK4JH1004

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention