BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2963490 · Received February 13, 2013

    Report

    Report Number
    1226188-2013-00005
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 10, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS 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 AND STERILIZATION RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN PATIENT INFECTION. ALL BATCH RECORDS, STERILIZATION AND STERILITY RESULTS WERE REVIEWED. THERE WERE NO DEVIATIONS.

    Description of Event or Problem · 1

    PATIENT REPORTEDLY HAD AN INFECTION IN THE LOWER LEG THAT MIGRATED TO THE IMPLANT. INITIAL SURGERY WAS ON (B)(6) 2012 AND REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63693 APEX KNEE SYSTEM DOVETAIL ULTRA TIBIAL INSERT CS JWH OMNLIFE SCIENCE, INC. SZ 4X12MM 9943

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R