BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3003964 · Received March 12, 2013

    Report

    Report Number
    1226188-2013-00021
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION AND THEREFORE OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING LOT RECORDS WAS PERFORMED. THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN LOOSENING OF IMPLANT IN THE PT. ALL IMPLANT LOT RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A KNEE REVISION SURGERY DUE TO PT'S KNEE BEING LOOSE. THE SURGEON REMOVED THE 4 X 14 MM ULTRA TIBIAL INSERT AND IMPLANTED A 4 X 18 MM ULTRA TIBIAL INSERT. THE REMOVED IMPLANTS WERE NOT RETURNED TO OMNI. THE ORIGINAL SURGERY WAS ON (B)(6) 2011 AND THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103845 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC 7308

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R