BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 1971884 · Received January 19, 2011

    Report

    Report Number
    1644408-2011-00038
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT HAD LIMITED RANGE OF MOTION. AN INSERT CHANGE AND REMOVAL OF SCAR TISSUE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE ULTRA CONGRUENT 500 SERIES INSERT JWH ENCORE MEDICAL, L.P. 53884236

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention