BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON CS INS SIZE 4 9MM

    MDR report key: 4221406 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04107
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING A SEATING ISSUE INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURNED COMPONENT INDICATES THAT THE INSERT MAY HAVE BEEN OBSTRUCTED DURING THE ATTEMPTED SEATING AND THAT THE INSERT WAS AT LEAST PARTIALLY ASSEMBLED WITH THE BASEPLATE. DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. COMPLAINT HISTORY REVIEW: CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE ARE NO OTHER SIMILAR EVENTS REPORTED. CONCLUSIONS: BASED ON THE VISUAL INSPECTION OF THE RETURNED COMPONENT, THE INSERT MAY HAVE BEEN OBSTRUCTED DURING THE ATTEMPTED SEATING AND THE INSERT WAS AT LEAST PARTIALLY ASSEMBLED WITH THE BASEPLATE. THE DAMAGE OBSERVED ON THE PART WAS CAUSED BY THE USER AND WOULD HAVE RENDERED THE COMPONENT UNUSABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LEFT TOTAL KNEE REPLACEMENT (TRIATHLON). SURGEON IMPLANTED A CEMENTED SIZE 4 TIBIAL BASEPLATE, A SIZE 4 PA FEMUR AND A CEMENTED 29MM ASYMMETRIC PATELLA. HE CHOSE TO USE A SIZE 4 9MM CS INSERT AND WHEN HE IMPACTED IT, IT WOULDN'T SEAT PROPERLY ON THE BASEPLATE. THE CS INSERT "BOUNCED" AND WAS SPRINGY ON THE MEDIAL SIDE AND WAS FLUSH ON THE LATERAL SIDE WHEN FULLY IMPACTED. THERE WAS NO TISSUE IMPINGEMENT SEEN. THE SURGEON WAS UNABLE TO SEAT THE INSERT ANY FURTHER, EVEN AFTER MORE IMPACTION. HE DECIDED TO REMOVE THIS CS INSERT AND REPLACE IT WITH A SIZE 4 9MM CR INSERT.

    Description of Event or Problem · 1

    LEFT TOTAL KNEE REPLACEMENT (TRIATHLON). SURGEON IMPLANTED A CEMENTED SIZE 4 TIBIAL BASEPLATE, A SIZE 4 PA FEMUR AND A CEMENTED 29MM ASYMMETRIC PATELLA. HE CHOSE TO USE A SIZE 4 9MM CS INSERT AND WHEN HE IMPACTED IT WOULDN'T SEAT PROPERLY ON THE BASEPLATE. THE CS INSERT "BOUNCED" AND WAS SPRINGY ON THE MEDIAL SIDE AND WAS FLUSH ON THE LATERAL SIDE WHEN FULLY IMPACTED. THERE WAS NO TISSUE IMPINGEMENT SEEN. THE SURGEON WAS UNABLE TO SEAT THE INSERT ANY FURTHER, EVEN AFTER MORE IMPACTION. HE DECIDED TO REMOVE THIS CS INSERT AND REPLACE IT WITH A SIZE 4 9MM CR INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701197 X3 TRIATHLON CS INS SIZE 4 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LDT842

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other