BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ2.5

    MDR report key: 3150015 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18320
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WERE NOT PROVIDED. ADDITIONAL EVENT INFORMATION AND INVESTIGATIONAL INPUTS WERE REQUESTED BUT NOT PROVIDED. THE FEMORAL AND TIBIAL PLATE LOOSENING CANNOT BE CONFIRMED. A LOT SPECIFIC SEARCH OF THE COMPLAINTS DATABASES AND/OR REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249900 MBT CEM TIBIAL TRAY SZ2.5 TIBIAL TRAY NJL DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention