BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 4 12.5

    MDR report key: 2033948 · Received March 17, 2011

    Report

    Report Number
    1818910-2011-04265
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FOR INSTABILITY, FOUND FRACTURED POST ON TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 4 12.5 87 NJL NJL DEPUY (IRELAND) NA 2971415

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention