REAL INTELLIGENCE ROB10018Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556757376), received between Apr 9, 2021 and Mar 30, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Degraded; Unstable

  IT WAS REPORTED THAT DURING A TKA, THE TEETH OF THE REAL INTELLIGENCE FEMUR TRACKER HAD WORN DOWN SO MUCH THEY MOVED WHILE ATTACHED TO THE CLAMP. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736421 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE REAL INTELLIGENCE FEMUR TRACKER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459681 ↗
• MalfunctionJun 6, 2025Degraded; Unintended Movement; Degraded; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THEY NOTICED THE REAL INTELLIGENCE FEMUR TRACKER HAVE WEAR AROUND WHERE THE CLAMPS TIGHTEN ON THE TRACKER FRAME. THEY WERE UNABLE TO COMPLETE TIBIA BONE REMOVAL BECAUSE OF THE MOVEMENT. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159192 ↗
• MalfunctionFeb 5, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, IT WAS NOTICED THAT THE REAL INTELLIGENCE FEMUR TRACKER HAD MOVED. THE FEMUR AND TIBIA CUTS WERE MADE PRIOR TO NOTICING THAT THE ARRAY MOVED. THE SURGEON WAS ABLE TO PROCEED WITH THE CASE, BUT UNABLE TO COLLECT POST OPERATIVE DATA. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO HARM CAUSED TO PATIENT, AS THE TRACKER MOVED POST BONE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313037 ↗
• MalfunctionDec 14, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHILE AT THE IMPLANT PLANNING STAGE WITH A REAL INTELLIGENCE CORI, THE DISTAL FEMORAL CONDYLES DID NOT SHOW UP IN THE CORONAL SCREEN. THE FEMORAL ARRAY HAD BEEN MOVED DURING THE START OF THE CASE; AS SUCH, THE CASE WAS CLEARED BACK TO THE START TO REDEFINE THE CHECKPOINTS AND THE LANDMARKS. WHEN THE IMPLANT PLANNING SCREEN WAS REACHED A SECOND TIME, THE DISTAL FEMORAL CONDYLES WERE AGAIN NOT WITHIN THE CORONAL VIEW. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME CORI CONSOLE, WITHOUT THE VISUALIZATION OF THE DISTAL CONDYLES. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325296 ↗
• MalfunctionNov 9, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, AFTER BURRING THE DISTAL FEMUR AND CHECKING 5-1 CUTTING JIG, IT WAS THEN NOTICED THAT THE REAL INTELLIGENCE FEMUR TRACKER HAD MOVED, IT WAS CHECKED THE CHECKPOINTS ON THE REAL INTELLIGENCE CORI CONSOLE AND IT WAS OFF BY A FEW MM, THEY THEN USED MANUAL INSTRUMENTATION TO CUT THE FEMUR AND USED THE ROBOT TO CUT THE TIBIA. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105067 ↗
• InjuryDec 29, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, WHILE THE SURGEON WAS BURRING THE DISTAL FEMUR, THE REAL INTELLIGENCE ROBOTIC DRILL STARTED MAKING A HIGHER PITCHED NOISE AND THEN JUST STOPPED AND AN ERROR MESSAGE WAS DISPLAYED. THEY GOT THE REAL INTELLIGENCE ROBOTIC DRILL SWITCHED OUT AND CONTINUED ON WITHOUT ISSUE. OTHER THAN THAT, AT SOME POINT THE REAL INTELLIGENCE FEMUR TRACKER MOVED AND THEY WERE NOT ABLE TO CONTINUE WITH THE ROBOTICS. THE PROCEDURE WAS FINISHED USING AN SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. ADDITIONALLY, THE RI ROBOTIC DRILL ATTACHMENT AND; THEREFORE, THE REAL INTELLIGENCE ROBOTIC DRILL TRACKER WERE LOCKED ON THE HANDPIECE AND COULD NOT BE REMOVED. THEY ALL TRIED AND EVEN USED PLIERS, IT WOULD NOT BUDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113227 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING UKR SURGERY WITH CORI, THEY PLANNED AND EXECUTED BOTH FEMUR AND TIBIA CUTS. DURING TRIALING OF THE FEMUR, THEY NOTICED THAT THE FEMUR CUTS AND PEG HOLES WERE "OFF" AND THE TRIAL WOULD NOT FIT PROPERLY. THEY CHECKED THEIR CHECKPOINT TO LOOK FOR TRACKER MOVEMENT AND THIS CONFIRMED THAT THE FEMUR TRACKER DID MOVE BY ~6MM. PRIOR TO CUTTING, DURING REFINE MODE, THEY CHECKED THE BORDERS OF THE IMPLANT AND THEY APPEARED TO BE WHAT THEY ANTICIPATED. SO, THEY ADVANCED AND EXECUTED WITHOUT REALIZING THERE MAY HAD BEEN MOVEMENT RIGHT AFTER REFINING OR DURING THE ACTUAL BURR PHASE THAT WENT UNNOTICED UNTIL AFTER THE FACT. DUE TO THE TRACKER MOVEMENT AT THIS POINT OF THE CASE THEY CHANGED TO MANUAL INSTRUMENTATION. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729799 ↗
• InjuryApr 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING CORI TKA PROCEDURE SURGEON STATES THE FEMUR TRACKING ARRAY (CASE-(B)(4)) AND THE TIBIA TRACKER ARRAY (CASE-(B)(4)) ARE BECOMING WORN DOWN WITH USE WHERE THE CLAMPS GRIP THE TEETH, AND THAT HE WAS NOT ABLE TO SECURE THEM AS TIGHTLY AS HE WOULD HAVE LIKED, EVEN WHEN USING THE CHECKPOINT TOOL. LATER ON, AFTER MAKING BOTH CUTS, THEY FAILED CHECKPOINT VERIFICATION ON THE FEMORAL ARRAY WITH AN ERROR OF 2.2MM. NO DELAY OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 11643828 ↗