BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION PS KNEE

    MDR report key: 1960276 · Received January 7, 2011

    Report

    Report Number
    1644408-2011-00014
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT HAD A LOOSE KNEE, THE DOCTOR CHANGED TO A LARGER INSERT TO STABILIZE THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION PS KNEE PS TIBIAL INSERT JWH ENCORE MEDICAL, L.P. 774001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention