BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 2973006 · Received February 21, 2013

    Report

    Report Number
    0002249697-2013-00742
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A GAP BETWEEN A TRIATHLON PS INSERT AND THE BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE CLEARANCE GAPS(0.1~0.5MM) BETWEEN TIBIAL INSERTS AND BASE PLATES AT MEDIAL AND LATERAL SIDES. THE GAPS WERE VISIBLE AT BOTH LEGS. THE SURGEON CONFIRMED THAT THESE INSERTS WERE LOCKED PROPERLY, SO HE DID NOT USE ANOTHER INSERTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE CLEARANCE GAPS (0.1~0.5MM) BETWEEN TIBIAL INSERTS AND BASE PLATES AT MEDIAL AND LATERAL SIDES. THE GAPS WERE VISIBLE AT BOTH LEGS. THE SURGEON CONFIRMED THAT THESE INSERTS WERE LOCKED PROPERLY, SO HE DID NOT USE ANOTHER INSERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76061 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLLD2J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other