BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/R POR FEM RT SZ4

    MDR report key: 1243053 · Received November 21, 2008

    Report

    Report Number
    1818910-2008-05746
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 26, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    THE PATIENT WAS REVISED BECAUSE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/R POR FEM RT SZ4 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. N/A 391214R

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention