BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2093730 · Received April 21, 2011

    Report

    Report Number
    1644408-2011-00221
    Event Type
    Other
    Date Received
    April 21, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT DID NOT HAVE FULL RANGE OF MOTION AND WAS TOO TIGHT. THE SURGEON REPLACED IMPLANT WITH A THINNER POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE 500 SERIES CONSTRAINED P.S. INSERT JWH ENCORE MEDICAL, L.P. 53813291

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention