BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG FLUT FEMROD 5DG 16X175MM

    MDR report key: 1625003 · Received March 5, 2010

    Report

    Report Number
    1818910-2010-00936
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LIGAMENT LAXITY, INSTABILITY. INTRAOPERATIVELY, DISCOVERED FEMORAL LOOSENING, POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG FLUT FEMROD 5DG 16X175MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 255227A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention