BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3538722 · Received December 19, 2013

    Report

    Report Number
    1226188-2013-00106
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    November 17, 2013
    Report Date
    November 19, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K102578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 BETWEEN THE DEVICE AND THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2013. THE ORIGINAL SURGERY WAS DATED (B)(6) 2013. BOTH SURGERIES INVOLVED IMPLANTATION OF OMNILIFE DEVICES. THE REVISION SURGERY WAS PERFORMED DUE TO PATIENT FALLING AND FRACTURING FEMUR. THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCES CONTRIBUTING TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664260 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC. 9444

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R