BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3122143 · Received May 17, 2013

    Report

    Report Number
    1226188-2013-00035
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 5, 2012
    Report Date
    April 22, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD ONLY USE THE IMPLANT USAGE TICKET INFORMATION TO CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN PATIENT FLEXION CONTRACTURE. ALL IMPLANT LOT RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED A KNEE REVISION SURGERY DUE PATIENT'S FLEXION CONTRACTURE. THE SURGEON REMOVED AND REPLACED THE TIBIAL INSERT AND FEMUR. THERE WERE NO IMPLANT ISSUES NOTED. THE ORIGINAL IMPLANT 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
    219188 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC. 8780

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R