BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM LT SZ 3

    MDR report key: 2011393 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03497
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K950010
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 INFECTION AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM LT SZ 3 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA HX73443M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention