BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK PIN AND CLIP

    MDR report key: 1190354 · Received October 3, 2008

    Report

    Report Number
    1818910-2008-04440
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K864671
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE PIN AND CLIP MECHANISM WERE NOT PROPERLY CONNECTED, WHEN REMOVING INSERT PIN DROPPED BELOW THE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMK PIN AND CLIP 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA AX2DK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention