BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3152547 · Received June 5, 2013

    Report

    Report Number
    1226188-2013-00041
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 10, 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

    EVALUATION SUMMARY: 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 AND STERILIZATION RECORDS WAS PERFORMED. ALL IMPLANT LOT RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED. THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD RESULT IN PATIENT INFECTION.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED A REVISION SURGERY DUE TO PATIENT INFECTION. THE SURGEON REMOVED ALL TKR COMPONENTS AND THEN PLACED A CEMENT SPACER WITH ANTIBIOTICS AND A TEMPORARY PATELLA AND TIBIAL INSERT. THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2013 AND THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247879 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC. 5976

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R