BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIP TRAY SZ3

    MDR report key: 1972370 · Received January 25, 2011

    Report

    Report Number
    1818910-2011-01018
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS INFECTION. THE TIBIAL TRAY WAS DOWNSIZED TO ADDRESS TIGHTNESS OF KNEE. THE TIBIAL AND FEMORAL COMPONENTS WERE BOTH LOOSE AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIP TRAY SZ3 87NJL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2154607

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention