BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM LT SZ 4

    MDR report key: 1013761 · Received March 13, 2008

    Report

    Report Number
    1818910-2008-00707
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 REVISED FOR SUSPECTED INFECTION (NOT CONFIRMED), FOUND FEMORAL AND TIBIAL COMPONENTS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM LT SZ 4 87JWH JWH DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS NA 335443

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention