BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OS KNEE UNIVERSAL

    MDR report key: 1656879 · Received April 9, 2010

    Report

    Report Number
    9617840-2010-00002
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    March 8, 2010
    Report Date
    April 9, 2010
    Manufacturer
    ZIMMER CAS
    Product Code
    HAW
    PMA / PMN Number
    K060336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 SYSTEM HAD FURTHERMORE DETECTED DURING THE SUBJECT CALIBRATION THAT THE CALIBRATION WAS DIFFERENT TO THE PRIOR CALIBRATION DATA AND PROMPTED THE USER TO VERIFY THE POINTER AND THE CALIBRATION STEPS. THIS CHECK WAS NOT PERFORMED AND THE USE OF THE SYSTEM WAS CONTINUED WHILE SIGNIFICANT INACCURACIES IN OTHER NAVIGATION PARAMETERS WERE BEING OBSERVED AND ADJUSTED FOR BY THE USER. THE LOCAL REP WAS ADVISED OF THE ABOVE FINDINGS TO AVOID FUTURE OCCURRENCES. NO FURTHER ACTION WILL BE TAKEN AT THIS POINT CONSIDERING THAT THE INCIDENT WAS RELATED TO USE ERROR WHICH IS COVERED IN THE SYSTEM LABELING INCLUDING THE USER DISPLAY INTERFACE, THAT THE RESULTING EFFECTS ARE NORMALLY VERY DETECTABLE, AND THAT THERE IS NO ADVERSE TREND ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    A PT INCURRED A PERIPROSTHETIC FEMORAL FRACTURE ABOUT TWO WEEKS FOLLOWING A NAVIGATED KNEE REPLACEMENT (TKR) SURGERY IN (B) (6). THE SURGEON INDICATED THAT IT WAS MULTIFACTORIAL INCLUDING AN ANTERIOR FEMORAL NOTCH THAT HAD BEEN INCURRED DURING THE TKR SURGERY, AS WELL AS MUSCULAR CONTROL ISSUES AND EXCESSIVE POST-SURGICAL ACTIVITIES. A NOTCH OF ABOUT 3 MM DEEP HAD BEEN REPORTEDLY OBSERVED AFTER THE BONE CUTS HAD BEEN COMPLETED DURING THE TKR SURGERY. THE SURGEON INDICATED THAT THIS HAD BEEN POTENTIALLY BEEN CONTRIBUTED TO BY THE NAVIGATION SYSTEM SINCE DURING THE TKR SURGERY, IT HAD BEEN OBSERVED THAT THE SELECTED LOCATION OF THE ANTERIOR CUT LINE AS DISPLAYED FROM THE NAVIGATION SYSTEM WAS ADEQUATELY POSITIONED TO AVOID NOTCHING. IT WAS ALSO REPORTED THAT OTHER POSITIONAL OUTPUTS FROM THE NAVIGATION SYSTEM WERE SIGNIFICANTLY INACCURATE WITH ADJUSTMENTS BEING PERFORMED BY THE SURGEON AS NEEDED DURING THE SURGERY. UPON REVIEW OF THE NAVIGATION SYSTEM LOGS, IT WAS FOUND THAT THE MAIN NAVIGATION INSTRUMENT, THE REGISTRATION POINTER, UPON WHICH THE SUBSEQUENT NAVIGATION PARAMETERS ARE BASED HAD BEEN INCORRECTLY CALIBRATED BY THE USER AS REQUIRED DURING THE SURGERY. THIS WOULD HAVE LIKELY CAUSED THE SYSTEM INACCURACIES THAT WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OS KNEE UNIVERSAL HAW (STEREOTAXIC INSTRUMENT) HAW ZIMMER CAS KNEE UNIVERSAL 2.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other