BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1565256 · Received December 21, 2009

    Report

    Report Number
    1644408-2009-00590
    Event Type
    Other
    Date Received
    December 21, 2009
    Date of Event
    December 2, 2009
    Report Date
    December 2, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K923277
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PT SUFFERED FROM IMPROPER PATELLA TRACKING "MVO RECONSTRUCTION". TOO MUCH BACK BEND IN KNEE, POLY EXCHANGE TO TIGHTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM TIBIAL INSERT, PRIMARY STD JWH ENCORE MEDICAL, L.P. 53971933

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention