BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON INSERT PS#7 13MM

    MDR report key: 4123217 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03625
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE CORRECTED. AN EVENT REGARDING A SEATING ISSUE INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS. THE INSERT WAS RETURNED WITHOUT THE LOCKING WIRE. THE SUPERIOR BEARING SURFACE OF THE INSERT IS LARGELY UNREMARKABLE. THE ANTERIOR FACE OF THE INSERT COMPONENT HAS BEEN DAMAGED AS A RESULT OF THE ATTEMPTED LOCKING AND SUBSEQUENT REMOVAL FROM THE BASEPLATE. THERE ARE INDENTS EVIDENT ON THE INFERIOR SURFACE OF THE INSERT. THERE ARE MARKS PRESENT ON THE POSTERIOR ASPECT OF THE COMPONENT WHICH APPEAR TO HAVE BEEN CAUSED BY THE INSERT ENCOUNTERING AN OBSTRUCTION DURING THE ATTEMPTED SEATING INTO THE BASEPLATE. THE OBSTRUCTION WOULD HAVE PREVENTED THE INSERT COMPONENT FROM BEING PLACED FULLY POSTERIOR ON THE BASEPLATE COMPONENT SO THAT IT COULD LOCK CORRECTLY. MEDICAL EVALUATION NOT PERFORMED AS THE REPORTED COMPONENT WAS NOT IMPLANTED. DEVICE HISTORY REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. COMPLAINT HISTORY REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE ARE NO OTHER SIMILAR EVENTS REPORTED. THERE ARE MARKS PRESENT ON THE POSTERIOR ASPECT OF THE COMPONENT WHICH APPEAR TO HAVE BEEN CAUSED BY THE INSERT ENCOUNTERING AN OBSTRUCTION DURING THE ATTEMPTED SEATING INTO THE BASEPLATE. THE OBSTRUCTION WOULD HAVE PREVENTED THE INSERT COMPONENT FROM BEING PLACED FULLY POSTERIOR ON THE BASEPLATE COMPONENT SO THAT IT COULD LOCK CORRECTLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY OF KNEE, DOCTOR PUT WIRE TRIAL INSERT IN PLACE. LOCKING WIRE WAS VISIBLE AT JUNCTION OF BASEPLATE AND POLY. IT WAS THEN DETERMINED THAT IT WAS NOT PROPERLY LOCKED IN. IT WAS THEN REMOVED AND REPLACED. INSERT WILL BE RETURNED BUT WIRE WAS LOST.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY OF KNEE, DOCTOR PUT WIRE TRIAL INSERT IN PLACE. LOCKING WIRE WAS VISIBLE AT JUNCTION OF BASEPLATE AND POLY. IT WAS THEN DETERMINED THAT IT WAS NOT PROPERLY LOCKED IN. IT WAS THEN REMOVED AND REPLACED. INSERT WILL BE RETURNED BUT WIRE WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602450 X3 TRIATHLON INSERT PS#7 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCR968

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other