BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIK UNI KNEE

    MDR report key: 1981201 · Received January 26, 2011

    Report

    Report Number
    1644408-2011-00044
    Event Type
    Other
    Date Received
    January 26, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HRY
    PMA / PMN Number
    K022437
    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 DOCTOR WANTED TO BALANCE THE KNEE LIGAMENTS. HE REMOVED THE INSERT AND REPLACED IT WITH A DIFFERENT SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIK UNI KNEE TIBIAL INSERT HRY ENCORE MEDICAL, L.P. 32581001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention