BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2931664 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00030
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD BILATERAL ENCORE FOUNDATION KNEES PUT IN ON THE (B)(6) 1998. THE SURGEON REVISED BOTH KNEES INSERTS DUE TO NORMAL WEAR. THE PT HAD 6X9 POSTERIOR STABILIZED TIBIAL INSERTS ON BOTH SIDES; ONE REPLACED WITH SAME SIZE THE OTHER REPLACED WITH A 6X11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34455 FOUNDATION KNEE POSTERIOR STABILIZED TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 323531

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention