BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC3 RP TIBIAL INSERT S3,10.0

    MDR report key: 1962338 · Received January 7, 2011

    Report

    Report Number
    1818910-2010-10097
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 LOOSE FEMORAL COMPONENT, FOUND BROKEN FEMORAL ADAPTER AND POLYETHYLENE WEAR OF INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC3 RP TIBIAL INSERT S3,10.0 87 NJL NJL DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS NA AD3JM4000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention