BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ3

    MDR report key: 1210518 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-04566
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED EVIDENCE INDICATING DEVICE LOOSENING IN VIVO. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE DEVICE LOOSENING; HOWEVER, LACK OF EVIDENCE OF ADHERED CEMENT SUGGESTS POOR FIXATION WAS A CONTRIBUTING FACTOR. NO EVIDENCE AS FUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT 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 TO ADDRESS LOOSENING OF THE TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIB TRAY SZ3 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA 2492437

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention