BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3659436 · Received February 18, 2014

    Report

    Report Number
    1226188-2014-00011
    Event Type
    Injury
    Date Received
    February 18, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 20, 2014
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED THE ADVERSE EVENT. REVIEW OF THE STERILITY RECORDS INDICATES NO DEVIATION TO STERILIZATION OR STERILITY RESULTS THAT COULD CONTRIBUTE TO INFECTION. THERE WAS NO REPORT OF DEFECT OR FAILURE TO MEET IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2014. THE ORIGINAL SURGERY WAS DATED (B)(6) 2012. BOTH SURGERIES INVOLVED IMPLANTATION OF OMNILIFE DEVICES. THE REVISION SURGERY WAS PERFORMED DUE TO INFECTION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103054 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC. 7258

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R