BEUDAMED
    FDA Adverse Event Other Summary report: N

    OS UNICONDYLAR KNEE UNIVERSAL

    MDR report key: 1899122 · Received October 26, 2010

    Report

    Report Number
    9617840-2010-00004
    Event Type
    Other
    Date Received
    October 26, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ZIMMER CAS
    Product Code
    HAW
    PMA / PMN Number
    K071714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS WAS DETERMINED FROM THE NAVIGATION SYSTEM COMPUTER LOGS, THE REGISTRATION POINTER HAD NOT BEEN FULLY INSERTED INTO THE CALIBRATION INSTRUMENT. IN ADDITION TO BEING INCLUDED IN THE USER INSTRUCTIONS, THIS REQUIREMENT IS GRAPHICALLY INSTRUCTED TO THE USER BY THE SYSTEM DISPLAY AT THE TIME IT IS BEING PERFORMED. THE RESULTING NOTABLE ACCURACY DISCREPANCIES WERE OBSERVED BY THE SURGEON AND THE SURGEON REVERTED TO MANUALLY ADJUSTING THE CUTTING JIGS PER STANDARD TECHNIQUES. THE LOCAL REP WAS ADVISED OF THE ABOVE FINDINGS TO REVIEW THE CALIBRATION STEPS WITH THE SURGEON TO AVOID FUTURE OCCURRENCES. A MEMO WILL BE SENT OUT TO ALL OTHER ACCOUNTS AS A REMINDER OF THE CALIBRATION STEP REQUIREMENTS AS INDICATED IN THE USER INSTRUCTIONS AND THE USER DISPLAY.

    Description of Event or Problem · 1

    A SURGEON OVER-RESECTED A PT'S TIBIA AND CORRESPONDINGLY USED AN 11 MM TIBIAL INSERT INSTEAD OF AN 8 MM ONE, AS PLANNED DURING A NAVIGATED UNICONDYLAR KNEE REPLACEMENT (UKR) SURGERY IN (B)(6). THE SURGEON WAS INITIALLY USING THE NAVIGATION SYSTEM TO DETERMINE AND ALIGN THE TIBIAL RESECTION BUT OBSERVED THAT THE DISPLAYED POSITIONAL DATA WAS ERRONEOUS. THE SURGEON THEN MANUALLY ADJUSTED THE CUTTING JIGS WITHOUT THE USE OF THE NAVIGATION SYSTEM. THE CUT WAS THEN PERFORMED AFTER WHICH THE OVER-RESECTION WAS OBSERVED. THE TIBIAL INSERT THICKNESS WAS THEN ADJUSTED AS NOTED ABOVE TO COMPENSATE FOR THE OVER-RESECTION. THE SURGERY WAS THEREAFTER SUCCESSFULLY COMPLETED WITH AN ESTIMATED 15 MIN INCREASE IN SURGICAL TIME. UPON REVIEW OF THE NAVIGATION SYSTEM LOGS, IT WAS FOUND THAT THE MAIN NAVIGATION INSTRUMENT UPON WHICH MOST OF THE POSITIONAL DATA IS DETERMINED, THE REGISTRATION POINTER, HAD BEEN INCORRECTLY CALIBRATED BY THE USER AS REQUIRED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OS UNICONDYLAR KNEE UNIVERSAL HAW (STEREOTAXIC INSTRUMENT) HAW ZIMMER CAS UNICONDYLAR-1.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention