BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 4123262 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03654
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED IN DAMAGED CONDITION. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE PROVIDED INFORMATION. VISUAL INSPECTION: THE RETURNED DEVICE IS IN DAMAGED CONDITION. MINIMAL LIGHT SCRATCHES WERE OBSERVED OF THE DISTAL AND BEARING SURFACE. THE LOCKING WIRE WAS FULLY DISENGAGED FROM THE INSERT AND THE PLASTIC SURROUNDING ITS INTENDED LOCATION WAS CRACKED AND DAMAGED. DIMENSIONAL INSPECTION: WAS NOT PERFORMED AS THE DAMAGE TO THE LOCKING FEATURES PREVENTS AN ACCURATE ASSESSMENT OF THE DEVICE'S AS-MANUFACTURED CONDITION. FUNCTIONAL INSPECTION: THE DAMAGE TO THE LOCKING FEATURE RENDERS THE DEVICE NON-FUNCTIONAL. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY DR BERNHARD ORIGINALLY IMPLANTED A 11 MM TRIAL INSERT THEN DECIDED TO GO UP ONE SIZE. A 13 MM WAS OPENED AND HE COULD NOT GET IT TO LOCK IN THE TIBIAL BASEPLATE. ANOTHER ONE WAS OPENED AND IT LOCKED IN PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY DR (B)(6) ORIGINALLY IMPLANTED A 11 MM TRIAL INSERT THEN DECIDED TO GO UP ONE SIZE. A 13 MM WAS OPENED AND HE COULD NOT GET IT TO LOCK IN THE TIBIAL BASEPLATE. ANOTHER ONE WAS OPENED AND IT LOCKED IN PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602715 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMHE09

    Patients

    Seq Age Sex Outcome Treatment
    1 Other