BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA C/S NPOR FEM LT SZ.5

    MDR report key: 1033967 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01515
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 26, 2008
    Manufacturer
    DEPUY - CORK A DIVSION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K971189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    LEFT TKR (PFC) BEING REVISED DUE TO PAIN/DISCOMFORT. INTRA-OPERATIVELY, BOTH FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO HAVE STABLE FIBROUS FIXATION ONLY. THE BONE CEMENT USED IN THE INDEX SURGERY WAS MANUFACTURED BY OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA C/S NPOR FEM LT SZ.5 87JWH JWH DEPUY - CORK A DIVSION OF DEPUY ORTHOPAEDICS NA 2008796

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention