BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3032198 · Received March 29, 2013

    Report

    Report Number
    1226188-2013-00024
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 4, 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 IMPLANTS WERE NOT RETURNED FOR EXAMINATION AND THEREFORE, OMNI USED THE IMPLANT USAGE TICKET TO CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFO PROVIDED, A REVIEW OF MANUFACTURING AND STERILIZATION RECORDS OF THE EXPLANTED IMPLANTS WAS PERFORMED. THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN WOUND DRAINAGE. ALL BATCH RECORDS, STERILIZATION, AND STERILITY RESULTS WERE REVIEWED. THERE WERE NO DEFECTS OR DEVIATIONS REPORTED.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A KNEE REVISION SURGERY ON (B)(6) 2016 DUE TO WOUND DRAINAGE TWO WEEKS POST-SURGERY. THE CULTURES INDICATED THAT THERE WAS NO INFECTION. THE SURGEON REMOVED THE TIBIAL INSERT AND RETAINING BOLT AND REPLACED THEM WITH NEW ONES. THE REMOVED IMPLANTS WERE NOT RETURNED TO OMNI. THE ORIGINAL SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130625 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC 5976

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R