BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ5

    MDR report key: 1870428 · Received October 11, 2010

    Report

    Report Number
    1818910-2010-07074
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED SAMPLE FOUND EVIDENCE SUGGESTING DEVICE LOOSENING WHILE IN VIVO. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING. POTENTIAL CONTRIBUTING FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PATIENT BONE QUALITY, CEMENT TECHNIQUE, CEMENT CURE TIME, AND PRODUCT SURFACE FINISH. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR OF THE INSERT, AND LOOSENING OF THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. IT WAS NOTED THAT THE FEMORAL COMPONENT HAD BECOME SO LOOSE THAT IT WAS COMPLETELY OFF THE ANTERIOR CORTEX, WITH NO CEMENT BONDED TO THE IMPLANT. THERE WAS ALSO SERIOUS BONE LOSS. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.

    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 NA 1800824

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention