BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 3 10.0

    MDR report key: 1210564 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-04735
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    DEPUY-CORK, A DIVIISON OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    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

    PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON IS ALSO CONCERNED ABOUT THE SCRATCHES ON THE INSERT, POSSIBLY CAUSED BY THIRD-BODY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 3 10.0 87NJL NJL DEPUY-CORK, A DIVIISON OF DEPUY ORTHOPAEDICS NA 2021871

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention