BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STP TB IN 3 12.5

    MDR report key: 1962483 · Received January 7, 2011

    Report

    Report Number
    1818910-2011-00228
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    PT REVISED DUE TO PAIN. PT FELL AND ALL COMPONENTS WERE LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STP TB IN 3 12.5 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA 2860184

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention