BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG POSTLIP INSERT SZ5 10MM

    MDR report key: 1222483 · Received November 5, 2008

    Report

    Report Number
    1818910-2008-04716
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INSUFFICIENT PCL STABILITY. POLY WEAR OF THE INSERT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG POSTLIP INSERT SZ5 10MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 51447A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention