BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 5053147 · Received September 3, 2015

    Report

    Report Number
    1226188-2015-00066
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 31, 2015
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. REVIEW OF THE MANUFACTURING AND STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2015. THE ORIGINAL SURGERY WAS DATED (B)(6) 2015. THE REVISION SURGERY WAS DUE TO INFECTION. IN THE REVISION, THE 35MM X 8MM DOME PATELLA AND SIZE 4 X 12MM INSERT WERE REVISED AND REPLACED WITH NEW IMPLANTS OF THE SAME SIZE AFTER AN ANTIBIOTIC TREATED CEMENT WAS PLACED IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583865 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMNILIFE SCIENCE, INC. 15746

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R