BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAKO ROBOTIC ARM 3.1

    MDR report key: 22293011 · Received June 19, 2025

    Report

    Report Number
    3005985723-2025-00271
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    August 19, 2025
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    07613327395280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING REGISTRATION FAILS INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS -PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES NOTED THE FOLLOWING: "REPEATED FAILURE OF FEMORAL BONE REGISTRATION IS DUE TO CAPTURE OF THE HIP CENTER IN A DIFFERENT LOCATION TO THE LOCATION OF THE CT LANDMARK, SEE EVENTS BELOW. 1. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR IS 0.57 (LINE 62) HIP CENTER WAS CAPTURED AND FAILED SEVERAL TIMES (LINES 45-55, 59-62). 2. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR IS 0.492 (LINE 63- 65). HIP CENTER NOT RECAPTURED AHEAD OF THIS BONE REGISTRATION ATTEMPT. 3. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR IS 0.55 (LINES 66¿ 68). 4. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR 0.79 (LINES 70¿ 72). 5. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR 0.88 (LINES 73-79). 6. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR 1.132 (LINES 86¿ 95). FROM LINES 86¿ 95, HIP CENTER LANDMARKS ARE CLEARED, AND REPEAT CAPTURE OF HIP CENTER GETS A PASSING CONDITION NUMBER (LINE 89). HOWEVER, THE HIP CENTER DISTANCE AND OFFSET ARE STILL HIGH WITH A VALUE OF 24.4 AND 17.4. THIS MAY INDICATE THAT THE CT LANDMARK WAS NOT CORRECTLY PLACED IN REFERENCE TO THE PATIENT LANDMARK. 7. IN LINES 96¿ 107 THE ANKLE CENTER IS RECAPTURED TWICE. IN THE FIRST ATTEMPT THERE IS A POOR LANDMARK SELECTION (LINE 98¿ 99; ANKLE CENTER OFFSET: 3.985) AND A CORRECT LANDMARK SELECTION FOR THE SECOND ATTEMPT (LINE 106-107). 8. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR 1.097 (LINES 113¿ 119). THE HIP CENTER WAS RECAPTURED (LINE 113¿ 115) BUT FAILED. 9. FEMORAL BONE REGISTRATION ATTEMPT: BONE REGISTRATION RMS ERROR 0.77 (LINES 129¿ 135). THE POINT CLOUD WAS CLEARED (LINE 129) AND POINTS WERE RECAPTURED BUT HEADING INTO THIS THE HIP CENTER IS STILL NOT PASSING. FROM LINES 146¿ 174 HAS MORE HIP CENTER CHANGES BUT BONE REGISTRATION STILL FAILING TO PASS. 10. LINE 175 TO 190 HIP CENTER IS CAPTURED ANOTHER AND POINT CLOUD IS RECAPTURED WITH FAILING BONE REGISTRATION 11. LINES 191 TO 214 CT LANDMARK HIP CENTER IS RECAPTURED 4 MORE TIMES WITH FAILING RESULTS. 12. LINES 215 TO 222 POINT CLOUD IS CLEARED AGAIN. 13. LINES 223 TO 247 HIP CENTER IS RECAPTURED FOUR MORE TIMES. THERE IS NO INDICATION OF SOFTWARE OR HARDWARE FAILURE IDENTIFIED IN THE LOGS PROVIDED. FAILURE TO PASS BONE REGISTRATION STEMS FROM A MISMATCH BETWEEN THE CT AND PATIENT HIP CENTER LANDMARK. THERE IS NO INDICATION OF A MISPLACED OR INCORRECT CT HIP CENTER. ALL PATIENT LANDMARK HIP CENTER CAPTURES PLACED PATIENT LANDMARK HIP CENTER MEDIAL INTO THE ACETABULUM BEHIND THE ACETABULAR SOCKET, WHICH WAS LATERAL TO THE LATERAL LOCATED CT LANDMARK. PLEASE NOTE THAT THIS IS NOT A PHYSICAL LOCATION WHICH A PATIENT HIP CENTER CAN BE LOCATED WITH SUCH REPEATABILITY OVER MULTIPLE HIP CAPTURES. PLEASE NOTE THAT A HIP CENTER CANNOT BE CAPTURED AFTER RESECTING THE FEMORAL HEAD. " -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE ARE NO OTHER COMPLAINTS WITH A SIMILAR FAILURE MODE FOR THIS LOT. CONCLUSIONS: BASED ON THE ANALYSIS OF THE RELEVANT LOG FILES AND SESSION FILES, THE ALLEGED FAILURE MODE CAN BE CONFIRMED TO HAVE BEEN CAUSED BY USER ERROR RELATED TO A MISMATCH BETWEEN THE CT AND PATIENT HIP CENTER LANDMARK. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    FEMORAL BONE REGISTRATION NOT PASSING DUE TO OVERALL ACCURACY BEING BEYOND THE LIMIT, AND THE LATERAL CONDYLE BONE REGISTRATION FOR BEING DEEMED SUFFICIENT. ALL TROUBLESHOOTING STEPS WERE FOLLOWED APPROPRIATELY, INCLUDING CHECKING THE DATE OF THE SCAN, THE CORRECT PATIENT PLAN WAS SELECTED, AND LATERALITY. CT LANDMARKS WERE CHECKED INTRA-OPERATIVELY, AND HIP CENTRE WAS CAPTURED A NUMBER OF TIMES TO ENSURE APPROPRIATE TECHNIQUE. BONE REGISTRATION WAS ATTEMPTED MULTIPLE TIMES, TOO. " PATIENT HAD TOURNIQUET ON FOR TOTAL OF 83 MINUTES. CASE WAS CONVERTED FROM MAKO TO MANUAL PROCEDURE. UPDATE: ROBOT PASSED ALL PRE-SURGERY CHECKS, RIO REGISTRATION, AND PROBE CHECKS PINS AND ARRAYS WERE TIGHT AND CORRECTLY POSITIONED IN ACCORDANCE WITH THE GUIDELINES AND WERE TIGHTENED APPROPRIATELY. HIP CENTRE (HC) WAS TAKEN THREE TIMES; THE FINAL TIME WAS WITHOUT THE LATERAL PELVIC SUPPORT ON THE BED TO ALLOW FOR FULL ROM AND ADEQUATE HC CAPTURE. FEMUR REGISTRATION ACCURACY WAS REPEATEDLY ABOVE THE 0.5MM THRESHOLD DESPITE REDOING A TOTAL OF 8 TIMES THROUGHOUT THE CASE; THE OVERALL ACCURACY RANGED FROM 0.6MM TO 1.1MM. THE FOLLOWING STEPS WERE TAKEN THROUGHOUT THE CASE TO TROUBLESHOOT: WALKING THE BONE: THE LATERAL CONDYLE AND CENTRE OF TROCHLEAR GROOVE KEPT COMING UP RED, INDICATING PROUD OF BONE, HOWEVER THE PROBE WAS CLEARLY ON HARD BONE, ANY FURTHER FORCE WOULD HAVE MADE HOLES IN THE FEMUR. RECAPTURING HIP CENTRE. GOING THROUGH CT LANDMARKS TOGETHER WITH THE SURGEON AND MAKING SMALL ADJUSTMENTS, DESPITE THERE BEING NO OBVIOUS ERRORS IN THEIR LOCATIONS; THIS REMAINED WITHIN THE GUIDELINES ON HWO TO SELECT CT LANDMARKS APPROPRIATELY. TIBIA PASSED BONE REG AND VERIFICATION. CHECKED PATIENT DETAILS (NAME AND DOB AND LATERALITY) ALL CORRECT. CHECKED SEGMENTATION, LOOKED FINE AS WELL. RE-TOOK HIP CENTRE AND FEMUR REGISTRATION ONE LAST TIME AND STILL 0.6 OVERALL ACCURACY, AND DISTANCE TO BONE REMAINED AT 2.5MM OR ABOVE. FURTHER CONTEXT: THIS IS A SURGEON WHO WAS CONDUCTING THEIR FIRST MAKO TKA. ALL OTHER SIDES OF THE FEMUR WERE YELLOW OR GREEN WITH NO OTHER AREAS OF CONCERN, AND WHEN WALKING THE BONE IN THE MEDIAL CONDYLE, AND IN ALL THREE VIEWS ON OTHER PARTS OF THE FEMUR (NOT THE LATERAL CONDYLE) THEIR DISTANCE TO BONE WAS ALL GREEN. THE DISTANCE TO BONE FOR THE LATERAL CONDYLE WAS INITIALLY 4MM, AND HAVING MADE SOME ADJUSTMENTS TO THE CT LANDMARKS, THIS CHANGED TO 2.5MM, AND BROUGHT THE OVERALL ACCURACY FROM 1.1MM TO 0.6MM; VARIOUS OVERALL ACCURACY FIGURES WERE LANDED ON IN BETWEEN, HAVING TRIED OTHER TROUBLESHOOTS. THE CASE WAS CONVERTED TO MANUAL AFTER 82 MINUTES (SINCE KNIFE TO SKIN).

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788156 MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 07613327395280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown