BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3223847 · Received July 10, 2013

    Report

    Report Number
    1226188-2013-00053
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 14, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC
    Product Code
    JWH
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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. DURING THE REVISION SURGERY THE ACETABULAR CUP, FEMORAL HEAD, FEMORAL NECK, FEMORAL STEM AND THE APICAL HOLE PLUG WERE REMOVED. 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 SALES REPRESENTATIVE REPORTED A HIP REVISION SURGERY DUE TO PATIENT INFECTION. THE SURGEON REMOVED ALL ACETABULAR CUP, FEMORAL HEAD, FEMORAL NECK, FEMORAL STEM AND THE APICAL HOLE PLUG. THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2011. THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316038 APEX KNEE SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED JWH OMNLIFE SCIENCE, INC 7379

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R