BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2170141 · Received June 29, 2011

    Report

    Report Number
    1644408-2011-00364
    Event Type
    Other
    Date Received
    June 29, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGERY WAS A PLANNED PATELLA RESURFACING ORIGINAL SURGERY WITH THE POSSIBILITY OF A POLY EXCHANGE, TIBIAL PLATE AND FEMORAL HEAD CHANGE. THE POLY WAS CHANGED DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE PS INSERT JWH ENCORE MEDICAL, L.P. 147521

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 312-01-106, LOT 150911| 204-01-008, LOT 166661