BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX+ DURAT STAB INSERT 12MM

    MDR report key: 1995518 · Received January 25, 2011

    Report

    Report Number
    9610726-2011-00013
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSX
    PMA / PMN Number
    K872735
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WAS REVISING A KINEMAX KNEE IMPLANT-THE PT WAS EXPERIENCING PAIN. PRE-OPERATIVE CONVERSATIONS WITH SURGEON INDICATED HE PLANNED TO POSSIBLY CHANGE THE PATELLA AND INSERT. HE REMOVED THE EXISTING INSERT (KINEMAX SMALL-10MM); TRIALED BOTH 10MM AND 12MM. REQUESTED A 12MM INSERT BE OPENED, THE INSERT WOULD NOT "SEAT PROPERLY INTO THE TIBIAL TRAY. AFTER SEVERAL (4 TO 6) ATTEMPTS TO SEAT THE INSERT, DR REQUESTED ANOTHER SMALL 12MM INSERT. I INFORMED THE SURGEON THAT NO OTHER INSERTS WERE ON SITE IN THAT SIZE. HE THEN ASKED FOR A SMALL-10MM INSERT WHICH WAS IMMEDIATELY "SEATED" PROPERLY INTO THE TIBIAL TRAY ON THE FIRST ATTEMPT. SURGEON THEN REQUESTED THAT THE 12MM INSERT WOULD HAVE SERVED THE PT'S NEEDS BETTER THAN THE 10MM INSERT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ DURAT STAB INSERT 12MM IMPLANT HSX STRYKER ORTHOPAEDICS LIMERICK NA LAP055

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other