BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON INSERT PS#7 16MM

    MDR report key: 3875211 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02295
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A X3 TRIATHLON INSERT PS#7 16MM WAS REPORTED. THE EVENT WAS CONFIRMED. THE LOCKING WIRE OF THE INSERT IS DISENGAGED FROM THE POLY AND THERE ARE MINOR SCRATCHES ON THE BODY OF THE DEVICE. DIMENSIONAL AND FUNCTIONAL EVALUATIONS WERE NOT PERFORMED AS THE DEVICE IS DAMAGED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. THE REPORTED EVENT INVOLVES THE LOCKING WIRE ON AN INSERT BEING NOT PROPERLY ENGAGED. THE INSERT WAS DISCARDED AND A NEW INSERT WAS IMPLANTED. IT IS LIKELY THAT THE EVENT IS A USER RELATED ISSUE WITH INSERTING THE DEVICE PROPERLY. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER NOTICED THE LOCKING WIRE ON A PS INSERT WAS NOT PROPERLY ENGAGED. THE SURGEON DISCARDED THIS ITEM AND INSERTED ANOTHER ONE.

    Description of Event or Problem · 1

    CUSTOMER NOTICED THE LOCKING WIRE ON A PS INSERT WAS NOT PROPERLY ENGAGED. THE SURGEON DISCARDED THIS ITEM AND INSERTED ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352049 X3 TRIATHLON INSERT PS#7 16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCT316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other