BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC PLI 15MM S6

    MDR report key: 1120712 · Received August 14, 2008

    Report

    Report Number
    1818910-2008-03385
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    November 22, 2004
    Report Date
    July 17, 2008
    Manufacturer
    DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    CLINICAL REPORT STATES THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC PLI 15MM S6 87JWH JWH DEPUY RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention