BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALANCED KNEE SYSTEM

    MDR report key: 1080995 · Received July 23, 2008

    Report

    Report Number
    1722511-2008-00011
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MFR. HOWEVER, SURGEON STATED THAT THE LOOSENING WAS DUE TO POOR BONE CEMENT.

    Description of Event or Problem · 1

    TIBIAL TRAY BECAME LOOSE. AS A RESULT THE TIBIAL INSERT, FEMORAL COMPONENT AND TIBIAL TRAY WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALANCED KNEE SYSTEM KNEE IMPLANT JWH ORTHO DEVELOPMENT CORP. 161-1503 00003133

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention