BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC* SIGMA C/S NPOR FEM RT SZ 3

    MDR report key: 1081195 · Received July 23, 2008

    Report

    Report Number
    1818910-2008-02865
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE, AS THE LOT CODE REQUIRED FOR RETRIEVAL WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC* SIGMA C/S NPOR FEM RT SZ 3 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA HX45353D

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention