NA 209999Recalls & reported problems

Summary

The FDA's MAUDE database contains 522 adverse event reports that list this exact device (DI 00848486030407), received between May 18, 2018 and Dec 10, 2025 — classified as 178 injuries, 344 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (190 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 522 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MPS INCLINATION AND VERSION OF CUPS IS NOT ACCURATE DURING REAMING AND IMPACTION. ROBOT SHOWS ACCURATE BUT DOES NOT MATCH POSTOPERATIVE X-RAY ASSESSMENTS. ISSUE OCCURRED OVER MULTIPLE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767267 ↗
• MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616129 ↗
• MalfunctionAug 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem

  IN A THA CASE, CUP PLACEMENT WAS ALLEGED TO BE INACCURATE. POSITION OF THE CUP IS NOT RIGHT AND THAT IT HAS NO ANTEVERSION; WE THEN DID AN INTRA OP XRAY. CUP NOT IN THE RIGHT POSITION (TOO FAR SUPERIOR), VISIBLE OVERHANG OF CUP. INCLINATION AND VERSION NOT AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770015 ↗
• MalfunctionAug 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716277 ↗
• MalfunctionApr 30, 2025Failure to Calibrate; Adverse Event Without Identified Device or Use Problem; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  MPS REPORTED THAT J6 ARM COULD NOT TRUN SO IT WAS NOT POSSIBLE PASS THE HOMING. THE CASE WAS CANCELED. FOUND ECEEDED THE BUMP STOP AND I FOUND DAMEGED BUMPSTOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934400 ↗
• InjuryApr 2, 2025Positioning Failure; Positioning Failure

  DURING MAKO CASE, THE KNEE WAS LOOSER THAN PLANNED (SHOWING 3DEG EXT DURING TRIALING AND IMPLANTATION. THEREFORE, CHECKED CUTS AND NOTICED DEEP TIBIAL CUT(1.3MM) AND DEEP DISTAL FEMORAL CUT (0.8). TRIAL AND IMPLANT FIT WAS GOOD BUT RESULTED IN SURGEON PUTTING IN A THICKER POLY INSERT 11MM AND SOME HYPEREXTENSION (3 DEG). LOT NUMBERS BELOW. GREEN PROBE 0.3, BLUE PROBE 1.0. ROBOT REG GOOD, VERIFICATION 0.39.

  Patient problems: Joint Laxity

  MAUDE report 21755733 ↗
• MalfunctionMar 20, 2025Failure to Calibrate; No Visual Prompts/Feedback; Failure to Calibrate; No Visual Prompts/Feedback

  MPS REPORTED THAT WHILE IMPACTION OCCURRED, A ROBOT PUSHED TOO HARD ERROR POPPED UP ON SCREEN. AFTER CLEARING THE ISSUE THE CUP VALUES CHANGED. CONFIRMED ROBOT POSITION WAS ADEQUATE, CONFIRMED THAT ROBOT ARM WAS NOT PUSHED AND THAT NO CHICKEN WING POSITION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653720 ↗
• InjuryFeb 5, 2025Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement

  MPS REPORTED THAT DURING THE TIBIAL CUT THE ARM MOVED RAPIDLY AND INJURED SOME OF THE SURROUNDING SOFT TISSUES. ON INSPECTION THE TIBIAL ARRAY WAS COMPROMISED (EXTREMELY LOOSE) AND IT ROTATED 90 DEGREES FROM THE ORIGINAL POSITION CAUSING THE ARM TO FOLLOW. TO COVER ALL BASES WE REQUESTED BOTH MAKO SYSTEMS TO BE TESTED TO MAKE SURE THEY WERE OPERATING CORRECTLY. ARM LOCKED IN PATIENT PROTOCOL FOLLOWED. PARTIAL DAMAGE TO MCL WHICH WAS REPAIRED BY SURGEON.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21316007 ↗
• MalfunctionJan 14, 2025Unintended System Motion; Application Program Freezes or Fails to Launch; Unintended System Motion; Application Program Freezes or Fails to Launch

  THE ROBOTIC ARM SHUTS OFF DURING SAWING DUE TO VELOCITY TRAP AND OFF-PLANE WARNINGS SEVERAL TIMES DURING EACH CUT. IT IS NOT A SMOOTH CUT AND HAS HAPPENED IN SEVERAL KNEES WITH MULTIPLE SURGEONS. IT HAPPENS AT LEAST 3 TIMES DURING EVERY CUT. IT DOESN¿T SOUND LIKE SMOOTH MECHANICS. CASE TYPE / APPLICATION: TKA 2.0. MPS REPORTED THAT DURING CUTS ON THE FEMUR OR TIBIA, THE MICS HANDPIECE FREQUENTLY LOSES POWER, CAUSING THE SAW TO STOP. THE ARM ALSO EXHIBITS SIGNIFICANT VIBRATION AND LOUD NOISE. THESE ISSUES OCCUR REPEATEDLY, AND THE SURGEON HAS REQUESTED IMMEDIATE RESOLUTION. THE PROBLEM HAS BEEN ONGOING FOR SEVERAL WEEKS AND HAS RECENTLY INTENSIFIED. MICS STATUS CHECKS AND MAKO REGISTRATION PASS WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147598 ↗
• MalfunctionJan 6, 2025Unintended System Motion; Positioning Problem; Unintended System Motion; Positioning Problem

  SURGEON REQUESTING SERVICE, HE SAYS THAT IT FEELS LIKE HE HAS TO LIFT THE ARM MORE TO KEEP IT ON PLANE WHILE CUTTING, IT FELT LIKE IT WAS HEAVIER, THE GRAVITY WAS OFF FROM WHAT HE IS USED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080881 ↗
• MalfunctionDec 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem

  SURGEON WAS NOT HAPPY WITH CUP PLACEMENT. AFTER PULLING POST-OP X-RAYS, HE DETERMINED INCORRECT VERSION. HE PLANNED FOR 45 INCLINATION AND 20 VERSION. HE SAYS THE CUP IS SIGNIFICANTLY RETROVERTED. CASE TYPE / APPLICATION: THA 4.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20986488 ↗
• MalfunctionNov 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem

  THIS PI IS FOR CASE 2 OF 2. MPS REPORTED BLADE UNABLE TO ALIGN TO TIBIA IN PLANAR WORKFLOW PKA ON FIRST CASE. BLADE ALIGNING, BUT OFF, SUCH THAT THE BLADE WOULD HAVE CUT THE MCL ON SECOND CASE. BURR HAPTICS APPEARED OK. ALTERING ROBOT POSITION DID NOT RESOLVE. LOWERING/RAISING BED DID NOT RESOLVE. EXTENDING/FLEXING/ROTATING LEG DID NOT RESOLVE. CHECKPOINTS PASS BEFORE AND AFTER CUTS, AND PHYSICAL CHECKPOINTS WERE USED IN TEXTBOOK LOCATION. CAMERA IS CLEAN. ROBOT WAS FULLY LOWERED WHEN ALIGNING TO AND EXECUTING CUTS. AS REPORTED VIA COMPLAINT FORM: DURING 2 PKA 3.0 CASES TODAY THE SYSTEM STRUGGLED TO CUT USING THE BLADE DURING TIBIA RESECTION. FIRST CASE THE BLADE WOULD NOT PROPERLY ALIGN. SECOND CASE THE BLADE WAS GROSSLY MORE MEDIAL THAN THE SCREEN WAS SHOWING. IF DOCTOR WERE TO CUT IT WOULD RESECT THE MCL AREA. HAD TO SWITCH TO BURR ONLY TO FINISH BOTH CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609616 ↗
• MalfunctionOct 31, 2024Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings

  MPS REPORTED SURGEON COMPLAINTS OF INACCURATE CUTS, WHERE POSTOP X-RAYS SHOWED VARUS COMPONENT FOR A VALGUS-PLANNED CASE. TIBIA CUT IS AFFECTED. POTENTIALLY MULTIPLE FEMUR CUTS ARE AFFECTED. CHECKPOINTS PASS BEFORE AND AFTER ALL CUTS. PLANAR PROBE CHECKS APPEAR TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582448 ↗
• MalfunctionOct 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS FOR TKA. MPS REPORTED THAT THE ROBOT HAS BEEN INACCURATE DURING SURGERY. FOR TKA, ALIGNMENT VALUES NEVER MATCH THE CLINICAL VALUES (E.G. SYSTEM WILL SHOW 0 DEGREES OF VARUS/VALGUS ALIGNMENT BUT CLINICAL RESULTS SHOW 11 DEGREES OF VALGUS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381880 ↗
• MalfunctionOct 4, 2024Positioning Failure; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Failure; Incorrect, Inadequate or Imprecise Result or Readings

  THE FOLLOWING WAS REPORTED "THE ROBOT HAS BEEN INACCURATE DURING SURGERY. FOR THA IT'S BEEN REALLY HARD TO REAM THE GREEN AWAY AND THE CUP WILL NOT SEAT FULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370905 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEG LENGTH DISCREPANCY. SURGEON WOULD LIKE TO HAVE REPORT DONE. CASE TYPE / APPLICATION: THA 4.1. UPDATE AS PER MPS RESPONSE ON 25 JULY 2024: ADDITIONAL INFORMATION RECEIVED, "1. WHAT IS THE SURGEON¿S PLAN FOR THIS PATIENT? UNKNOWN. 2. WHICH SIDE WAS THE OPERATIVE SIDE? LEFT. 3. IS THE OPERATIVE SIDE LONGER OR SHORTER THAN THE OTHER SIDE? LONGER. 4. LENGTH OF DISCREPANCY (MM): APPROXIMATELY 10MM".

  Patient problems: Unequal Limb Length

  MAUDE report 20263778 ↗
• MalfunctionSep 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Calibrate

  THIS PI IS FOR CASE 2 OF 2. MPS SAYS THAT DURING THA REAMING THEIR INCLINATION AND VERSION WAS OFF BY A LOT IN A CASE LAST WEEK WHICH HE THINKS IS A SUBOPTIMAL (EXTRA-ARTICULAR SURFACE POINTS) HOWEVER IN THE CASE TODAY THEY WENT TO REAM AND BEFORE ACTUALLY POWERING THE MICS THE SYSTEM SHOWED THAT THE ACETABULUM WAS REAMED TO THE POINT OF BEING RED. HE SAID CHECKPOINTS PASSED AND REGISTRATION WAS ACCURATE. THE SURGEON IS REQUESTING A DISPATCH. UPDATE 12/AUGUST/2024: MPS REPORTED INCLINATION AND VERSION INACCURACY DURING THA, WHICH MPS ATTRIBUTES AS POSSIBLY LINKED TO POOR REGISTRATION PATTERN + RED ALREADY SHOWING UP PRIOR TO REAMING. RE-REGISTRATION DID NOT RESOLVE. CHECKPOINTS BEFORE AND AFTER CUT ATTEMPTS PASSED. THIS SUPPORT CASE AND WORK ORDER ARE BEING SUBMITTED DUE TO A SPONTANEOUS CANCELLATION OF A PRIOR WORK ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143114 ↗
• MalfunctionAug 30, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS PI S FOR CASE 1 OF 2 MPS SAYS THAT DURING THA REAMING THEIR INCLINATION AND VERSION WAS OFF BY A LOT IN A CASE LAST WEEK WHICH HE THINKS IS A SUBOPTIMAL (EXTRA-ARTICULAR SURFACE POINTS) HOWEVER IN THE CASE TODAY THEY WENT TO REAM AND BEFORE ACTUALLY POWERING THE MICS THE SYSTEM SHOWED THAT THE ACETABULUM WAS REAMED TO THE POINT OF BEING RED. HE SAID CHECKPOINTS PASSED AND REGISTRATION WAS ACCURATE. UPDATE 12/AUGUST/2024: MPS REPORTED INCLINATION AND VERSION INACCURACY DURING THA, WHICH MPS ATTRIBUTES AS POSSIBLY LINKED TO POOR REGISTRATION PATTERN + RED ALREADY SHOWING UP PRIOR TO REAMING. RE-REGISTRATION DID NOT RESOLVE. CHECKPOINTS BEFORE AND AFTER CUT ATTEMPTS PASSED. THIS SUPPORT CASE AND WORK ORDER ARE BEING SUBMITTED DUE TO A SPONTANEOUS CANCELLATION OF A PRIOR WORK ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20110969 ↗
• MalfunctionMar 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  INACCURACY DURING PKA CASE. THE TIBIAL IMPLANT ISN'T PLACED IN THE SAME POSITION AS THE IMPLANT PLANNING. ALL THE VERIFICATIONS ON THE SCAN ARE CORRECT. ADDITIONAL INFORMATION: YES A REVISION HAS BEEN DONE DURING THE CASE. IMPLANT WAS CEMENTED AND REMOVED TO PLACE A NEW IMPLANT FROM THE SAME SIZE. AN ENGINEER CAME DURING THE WEEKEND TO FIX THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940305 ↗
• InjuryFeb 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY MPS: "SURGEON COMPLETED AN OFF LABEL CONVERSION OF A (MAKO) UNICONDYLAR KNEE REPLACEMENT TO A TOTAL KNEE REPLACEMENT. THE SURGEON REPORTED THAT THE POPLITEUS WAS CUT WHILE USING THE ROBOT TO MAKE CUTS."

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660025 ↗
• MalfunctionJan 22, 2024Unintended Movement; Unintended Movement

  MPS WAS IN A THA CARE AND WHILE THE SURGEON WAS APPROACHING FOR REAMING HE FELT A JOLT MOVEMENT OF THE ARM. MPS THEN WENT TO TEST REAMER AND BONE CHECKPOINTS AND BOTH OF THEM PASSED. HE SAID WHEN THE SURGEON THEN WENT TO RUT THE REAMER BACK INTO THE ACETABULUM THE CENTER OF ROTATION WAS OFF BY 5-8 MM POSTERIOR. HE RESTARTED ARM SOFTWARE AND THEN THE SYSTEM BUT THEY BAILED MANUAL. HE PERFORMED PRE-SURG CHECKS BEFORE THE NEXT CASE AND ALL OF THEM PASSED. IN THE NEXT CASE EVERYTHING WAS TOTALLY FINE. SURGEON IS REQUESTING DISPATCH LOGS AND FILE TO BE SENT AND A COMPLAINT IS TO BE FILED. THEY BAILED TO MANUAL ON THE FIRST CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550388 ↗
• MalfunctionDec 13, 2023No Visual Prompts/Feedback; No Visual Prompts/Feedback

  DURING A MAKO THA, WHEN WE BROUGHT THE ROBOT INTO REAM THE ACETABULUM THE VERSION NUMBERS DISPLAYED ON THE MONITOR LOOKED OFF AND DID NOT MATCH WHAT WE WERE VISUALLY SEEING. CHECKPOINTS RE VERIFIED AND ALL WERE PASSING AT APPROX 0.6MM. RE SET ARM SOFTWARE ALL FINE, WENT BACK INTO CASE PLAN SAME INCORRECT NUMBERS DISPLAYED, RE REGISTERED ROBOT AND ISSUE REMAINED. AT THIS STAGE WE WENT TO MANUAL REAMING AND CUP IMPACTION. SURGICAL RESULTS OBTAINED AND SAME INCLINATION NUMBER OF 60 REMAINED, DESPITE HAVING PLANNED IT AT 40. VISUALLY THE IMPACTED CUP VERSION LOOKED THE SAME AS THE PLANNED CUP VISUAL ON THE 3D PLAN, CONFIRMED WITH MANUAL ALIGNMENT HANDLE THAT 40/20 VERSION INCLINATION WAS OBTAINED. FINAL REDUCTION RESULT SHOWED THE CUP POSITION AT THE INCORRECT VERSION NOT WHAT WAS ACTUALLY SEEN IN THE PATIENT. PATIENT WAS UNDER ANAESTHESIA AT THE TIME WITH A DELAY OF APPROX 15 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316655 ↗
• MalfunctionDec 7, 2023No Visual Prompts/Feedback; Application Program Freezes or Fails to Launch; No Visual Prompts/Feedback; Application Program Freezes or Fails to Launch

  SETUP: CLEANED CABLES BEFORE CONNECTING, ROBOT PASSED ALL PRE SURGERY CHECKS. RIO REGISTRATION & INTRA OP BALANCING: ALL NORMAL. LEFT LEG (PKA) BONE PREP: - TIBIA FLOOR & FEMUR POSTERIOR CUT (SAW) - NORMAL - FEMUR DISTAL/ KEEL/PEGS (BURR) - NORMAL - TIBIA WALL(BURR)- FROZE - SURGEON ALIGNED AND STARTED BURRING UNTIL MIDWAY THE TIBIA WALL, THEN THE SCREEN FROZE, BUT BURR COULD STILL GO ON. IMMEDIATELY TOLD SURGEON TO RELEASE THE TRIGGER AND TO TAKE THE BURR AWAY FROM THE PATIENT. AFTER FEW SECONDS FROM THE TRIGGER RELEASE, ARM LOCK OCCURRED - KEYBOARD NO REACTION TO ALT+PRTSCR+K. LITTLE BUTTON ON THE BACK OF THE GUIDANCE MODULE HAS RESPONSE, WAITED 3 MINUTES BUT COULD NOT LEAD TO SOFTWARE REBOOT. DECIDED TO PROCEED WITH HARD SHUT DOWN. - WENT TO E STOP AND BRAKE RELEASE REMOVE THE ARM EVEN MORE AWAY FROM THE PATIENT AND PUT IN HOLSTER POSITION TO FACILITATE HOMING LATER ON. - HARD SHUT DOWN, TURNED ON ROBOT, DELETED SOME PLANS, ARM STATUS CHECK ALL GREEN, HOMING, WENT BACK INTO CASE, CONTINUE BURR - TIBIA WALL CUT, IN THE MODEL SHOWS HAVEN'T BURRED ANYTHING, BUT BEFORE THE SCREEN FROZE, THE MODEL SHOWED SURGEON BURRED THE ANTERIOR PART ALREADY. GUIDED THE SURGEON TO CLEAN ALL THE GR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281616 ↗
• MalfunctionSep 28, 2023Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem; Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Problem

  WHILE PLACING THE TIBIAL TRIAL, THE SURGEON MADE A COMMENT ABOUT THE BASEPLATE NOT SITTING ON THE MEDIAL CORTICAL RIM. THAT IT WAS PUSHED LATERAL TOWARDS THE EMINENCE CONSIDERABLY. THE TIBIAL CHECKPOINT GAVE A VALUE OF 3.8MM, WALKED THE BONE AND REALIZED WE HAD A BUMPED ARRAY. PKA 3.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836252 ↗
• MalfunctionSep 22, 2023Unintended Movement; Unintended Movement

  (B)(6) : MPS REPORTED DIFFICULTY ENTERING INTO AND STAYING INSIDE HAPTIC BOUNDARIES + ARM DRIFTING WITHOUT TRIGGER PULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799029 ↗