BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT POR TIBIAL TRAY SZ2.5

    MDR report key: 1903362 · Received November 16, 2010

    Report

    Report Number
    1818910-2010-08736
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 1 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    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 PRESENTED WITH PAIN AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309397 MBT POR TIBIAL TRAY SZ2.5 87NJL NJL DEPUY INTERNATIONAL, LTD. NA 2184346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention