BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLASSIC BIPOLAR FEMORAL HEAD

    MDR report key: 10733739 · Received October 26, 2020

    Report

    Report Number
    3008544874-2020-00001
    Event Type
    Injury
    Date Received
    October 26, 2020
    Report Date
    September 17, 2020
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    KWY
    UDI-DI
    00814703012181
    PMA / PMN Number
    K143113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS DUE TO IMPROPER USE OF THE KLASSIC BIPOLAR FEMORAL HEAD AND KLASSIC OFFSET FEMORAL STEM BY MATING THEM WITH IMPLANTS FROM STRYKER MDM X3 SYSTEM, AGAINST THE PROVIDED INSTRUCTIONS FOR USE OF BOTH SYSTEMS. USE OF THESE IMPLANTS WITH THE STRYKER IMPLANTS IS AGAINST SUPPLIED INSTRUCTIONS AND INTENDED USE AND THE DESIGN WAS NOT INTENDED FOR SUCH USE. THE REP HAS CONFIRMED THAT THE DEVICES WILL NOT BE RECOVERED FOR FURTHER INVESTIGATION. WITHOUT RETURN OF THE IMPLANTS PHYSICAL INVESTIGATION OF THE PARTS CANNOT BE COMPLETED ANY FURTHER. TOTAL JOINT ORTHOPEDICS IS SUBMITTING THIS AS A VOLUNTARY REPORT AS OUR IMPLANTS WERE USED OFF LABEL.

    Description of Event or Problem · 1

    PATIENT HAD PAIN STARTING 6 MONTHS AGO. ORIGINALLY DIAGNOSED AS PSOAS IMPINGEMENT AND GAVE PATIENT AN INJECTION. INJECTION DIDN'T HELP SO LABS WERE DONE. LABS SHOWED NO INFECTION AND SLIGHTLY ELEVATED COBALT CHROMIUM LEVELS AT 7. WENT TO 12 LAT MONTH AND COBALT CHROMIUM LEVELS HAD ALMOST DOUBLED IN A FEW MONTHS. CT AND MRI WERE PRETTY NORMAL. REVISION SURGERY WAS DONE. FEMORAL STEM SHOWED DAMAGE BELOW THE TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202096 KLASSIC BIPOLAR FEMORAL HEAD FEMORAL HEAD KWY TOTAL JOINT ORTHOPEDICS, INC. 3200.28.350 197197 00814703012181

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention KLASSIC OFFSET FEMORAL STEM 3103.04.000 TJ-4911141| MDM LINER 626-00-42E 52740704| RESTORATION ADM/MDM X3 INSERT FOR ADM/MDM| TRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL