BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ5

    MDR report key: 1250768 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05629
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE MANUFACTURING LOTS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING OR INFECTION. INFECTION AFTER APPROXIMATELY 2-1/2 YEARS IMPLANTATION IS UNLIKELY TO BE PRODUCT RELATED. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVED BECAUSE OF INFECTION WITH LOOSENING OF THE FEMORAL COMPONENT, TIBIAL COMPONENT AND PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM TIBIAL TRAY SZ5 87NJL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS N/A 2021006

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention