BEUDAMED
    FDA Adverse Event Summary report: N

    PFC SIGMA STAB INS S2.5 15MM

    MDR report key: 2191899 · Received May 29, 2008

    Report

    Report Number
    1818910-2008-01825
    Date Received
    May 29, 2008
    Report Date
    May 1, 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
    DC, US
    Reporter Occupation
    ATTORNEY

    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

    LETTER FROM ATTORNEY CLAIMS THAT PT WAS REVISED BECAUSE "THE POLYETHYLENE CUSHION BETWEEN THE TWO PIECES OF METAL DISINTEGRATED. IN ADDITION, A PORTION OF THE LOWER METAL PIECE, ON WHICH THE CUSHION RESTED, ACTUALLY BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STAB INS S2.5 15MM 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 72068A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention