BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1841639 · Received September 10, 2010

    Report

    Report Number
    1644408-2010-00477
    Event Type
    Other
    Date Received
    September 10, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K932425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PT HAD INSTABILITY. THE SURGEON DETERMINED THE STANDARD TIBIAL INSERT NEEDED TO BE REPLACED WITH AN ULTRA CONGRUENT INSERT DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE BASEPLATE, STEMMED, NON POROUS JWH ENCORE MEDICAL, L.P. 464822

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 120-01-029, LOT 465692| 201-01-104, LOT 462072