BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 3223809 · Received July 10, 2013

    Report

    Report Number
    1226188-2013-00055
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    February 29, 2012
    Report Date
    June 17, 2013
    Manufacturer
    OMNILIFE SCIENCE, INC
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO OMNI IMPLANTS WERE EXPLANTED OR REVISED. NO IMPLANT WAS RETURNED FOR EXAMINATION. OMNI COULD ONLY USE THE IMPLANT USAGE TICKET INFORMATION TO CONFIRM THE LOT NUMBERS OF THE PRODUCTS ORIGINALLY IMPLANTED. 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. DURING THE REVISION SURGERY THE PATELLA WAS RESURFACED. THERE WAS NO REPORT OF DEFECT OR FAILURE TO MEET IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF ANY OMNI DEVICE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED A KNEE REVISION SURGERY DUE TO PAIN AND IRRITATION. THE ORIGINAL IMPLANT SURGERY WAS ON (B)(6) /2012. OMNI DEVICES THAT WERE IMPLANTED WERE A FEMORAL HEAD, TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT. THE REVISION SURGERY WAS ON (B)(6) 2013. DURING THE REVISION SURGERY THE SURGEON RESURFACED THE PATELLA. NO OMNI DEVICES WERE EXPLANTED OR REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316136 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNILIFE SCIENCE, INC 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization