BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1981266 · Received February 2, 2011

    Report

    Report Number
    1644408-2011-00050
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    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 POLY BROKE, POSSIBLE DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE PS SERIES 500 INSERTS JWH ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention