BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI DUR REG FLUTED STEM 15X80MM

    MDR report key: 3781127 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01707
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K973164
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING DISASSOCIATION INVOLVING A TITANIUM STEM EXTENDER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE THREADS OF THE TIBIAL STEM ARE DAMAGED AND THE SHOULDER THAT MATCHES THE TIBIAL TRAY SHOWED WEAR CONSISTENT WITH FAILURE OF THIS THREADED JUNCTION. DAMAGES OBSERVED INSIDE THE TIBIAL TRAY WOULD BE CONSISTENT WITH THE STEM BECOMING LOOSE INSIDE THE TIBIAL TRAY. WHEN THE STEM BECAME LOOSE WAS NOT POSSIBLE TO BE DETERMINED. SOME BONE CEMENT IS STILL ATTACHED TO THE STEM. THE STEM IS ALSO SEVERELY SCRATCHED WHICH MOST LIKELY OCCURRED DURING EXPLANTATION. MEDICAL RECORDS RECEIVED AND EVALUATION: X-RAYS CONFIRM BONE LOSS BEHIND BOTH FEMORAL AND TIBIAL COMPONENT WITH A REPORTED NON-DISPLACED FEMORAL CONDYLAR FRACTURE. ROOT FAILURE MECHANISM RELATES TO THE USE OF CEMENTED FIXATION FOR THE TIBIAL STEM EXTENDER WHICH LEAD TO UNCOUPLING FROM THE BASEPLATE WHEN THE BASEPLATE BECAME LOOSE BECAUSE OF THE CONTINUOUS ROTATORY MOVEMENTS DURING GAIT CREATING AN OVERLOAD ON THE CONNECTION BETWEEN STEM EXTENDER AND BASEPLATE CONNECTOR BETWEEN LOOSE AND WELL-FIXED SECTION OF THE DEVICE CONSTRUCT. NO ARGUMENTS FOR EITHER DEVICE-RELATED OR PATIENT-RELATED FACTORS AND AS SUCH ROOT CAUSE OF FAILURE WITH REGARD TO UNCOUPLING OF THE DEVICE WITH ALL ITS SECONDARY EFFECTS OF METAL DEBRIS GENERATION IS PROCEDURE-RELATED AND NOT DEVICE-RELATED AS ALSO SUPPORTED BY THE MAR FINDINGS. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE TIBIAL LOOSENING WAS CAUSED BY THE USE OF CEMENTED FIXATION FOR THE TIBIAL STEM EXTENDER WHICH LEAD TO UNCOUPLING FROM THE BASEPLATE WHEN THE BASEPLATE BECAME LOOSE BECAUSE OF THE CONTINUOUS ROTATORY MOVEMENTS DURING GAIT CREATING AN OVERLOAD ON THE CONNECTION BETWEEN STEM EXTENDER AND BASEPLATE CONNECTOR BETWEEN LOOSE AND WELL-FIXED SECTION OF THE DEVICE CONSTRUCT. THE ROOT CAUSE OF FAILURE WITH REGARD TO UNCOUPLING OF THE DEVICE WITH ALL ITS SECONDARY EFFECTS OF METAL DEBRIS GENERATION IS PROCEDURE-RELATED AND NOT DEVICE-RELATED AS ALSO SUPPORTED BY THE MAR FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO SURGEON WITH KNEE PAIN. X-RAY SHOWS POTENTIAL LOOSENING ON BOTH FEMUR AND TIBIA. UPON INCISION ON THIS REVISION THE TISSUES WERE BLACK FROM METAL DEBRIS. WHEN REMOVING THE TIBIA, THE STEM HAD SEPARATED FROM THE BASEPLATE. THIS IS WHAT IS SURMISED AS BEING THE REASON FOR THE DEBRIS DUE TO CONSTANT SHIFTING OF THE TIBIA, BROKE THE THREADS OF THE STEM TO TIBIA AND RUBBED. THIS WAS TOLD AS CONJECTURE BY SURGEON DURING CASE. COMPLETE DEBRIDEMENT WAS DONE. REVISION WITH A DEPUY REVISION KNEE WAS SUCCESSFULLY DONE BY SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO SURGEON WITH KNEE PAIN. X-RAY SHOWS POTENTIAL LOOSENING ON BOTH FEMUR AND TIBIA. UPON INCISION ON THIS REVISION THE TISSUES WERE BLACK FROM METAL DEBRIS. WHEN REMOVING THE TIBIA, THE STEM HAD SEPARATED FROM THE BASEPLATE. THIS IS WHAT IS SURMISED AS BEING THE REASON FOR THE DEBRIS DUE TO CONSTANT SHIFTING OF THE TIBIA, BROKE THE THREADS OF THE STEM TO TIBIA AND RUBBED. THIS WAS TOLD AS CONJECTURE BY SURGEON DURING CASE. COMPLETE DEBRIDEMENT WAS DONE. REVISION WITH A DEPUY REVISION KNEE WAS SUCCESSFULLY DONE BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259604 TI DUR REG FLUTED STEM 15X80MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH TRN619

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other