BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 2101160 · Received May 18, 2011

    Report

    Report Number
    1644408-2011-00280
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    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'S HIP WAS UNSTABLE. THE DOCTOR REPLACED IT WITH A CONSTRAINED INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE P.S. INSERT JWH ENCORE MEDICAL, L.P. 908401

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention