REAL INTELLIGENCE ROB10020Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556757390), received between Mar 18, 2021 and Feb 16, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Unintended Movement

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, SURGEON HAS HAD A FEMUR ARRAY MOVEMENT ERROR. HE SUSPECTED THAT THE REAL INTELLIGENCE TRACKER CLAMP USED HAD LOOSENED AND DID NOT REMAIN TIGHT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344399 ↗
• MalfunctionFeb 10, 2026Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, ONE (1) REAL INTELLIGENCE TRACKER CLAMP, ONE (1) REAL INTELLIGENCE FEMUR TRACKER, AND ONE (1) REAL INTELLIGENCE TIBIA TRACKER HAVE BEEN HAVING ISSUES WITH MOVING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310504 ↗
• MalfunctionFeb 10, 2026Unintended Movement

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, ONE (1) REAL INTELLIGENCE TRACKER CLAMP, ONE (1) REAL INTELLIGENCE FEMUR TRACKER, AND ONE (1) REAL INTELLIGENCE TIBIA TRACKER HAVE BEEN HAVING ISSUES WITH MOVING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310494 ↗
• MalfunctionJan 15, 2026Unstable

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI, THERE HAS BEEN AN ARRAY MOVEMENT ERROR, IT IS SUSPECTED THAT THE REAL INTELLIGENCE TRACKER CLAMP IS LOOSENING AND IS NOT REMAINING TIGHT. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED OR IF A DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078543 ↗
• MalfunctionJan 9, 2026Unstable

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI, THERE HAS BEEN AN ARRAY MOVEMENT ERROR, IT IS SUSPECTED THAT THE REAL INTELLIGENCE TRACKER CLAMP IS LOOSENING AND IS NOT REMAINING TIGHT. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019811 ↗
• MalfunctionNov 28, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, THE CHECKPOINTS WERE CHECKED SUCCESSFULLY AND A DISTAL FEMUR CUT WAS PERFORMED. THE CUT BLOCK WAS THEN PLACED ON FEMUR, AND WHEN THE POSITION WAS CHECKED, ONE (1) REAL INTELLIGENCE TRACKER CLAMP NOTABLY MOVED ON FEMUR PINS AS THE PLANE VISUALIZER DISPLAYED THAT THE BLOCK ON THE SCREEN APPEARED 8 DEGREES OFF FROM PLAN IN VARUS/VALGUS. CHECKPOINTS REVEALED FEMUR TRACKER MOVEMENT AND THE FEMUR CHECKPOINT WAS OFF BY 7 MM. IT WAS VERIFIED NO TIBIAL CHECKPOINT MOVEMENT AND THE CASE WAS CONTINUED AS PLANNED; HOWEVER, THE FEMUR ARRAY WAS NOT VALID FOR FINAL ROM AND STRESSED TESTING. THE PROCEDURE WAS FINISHED AFTER A NON-SIGNIFICANT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805737 ↗
• MalfunctionFeb 5, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, DURING POINT CALIBRATIONS, A REAL INTELLIGENCE TRACKER CLAMP BECAME LOOSE. THE CLAMP WAS THEN RE-TIGHTENED, HOWEVER, CAME LOOSE AGAIN LATER IN PROCEDURE. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, USING MANUAL INSTRUMENTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647112 ↗
• MalfunctionDec 12, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, TWO (2) REAL INTELLIGENCE TRACKER CLAMP BECAME LOOSE. THE CLAMPS WERE THEN RETIGHTENED BUT THEN CAME LOOSE AGAIN LATER IN PROCEDURE. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY BY MANUAL PROCEDURE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310476 ↗
• MalfunctionNov 22, 2023Unstable; Unstable

  IT WAS REPORTED THAT, AFTER A CORI ASSISTED SURGERY, TWO (2) REAL INTELLIGENCE TRACKER CLAMP WERE CONFIRMED TO BE STABILIZED WHEN TIGHTENING THE TRACKER, BUT THEN BECAME LOOSE. SINCE THIS ISSUE WAS NOTICED AFTER THE PROCEDURE, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192361 ↗
• MalfunctionNov 16, 2023Unstable; Unstable

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHEN TIGHTENING THE REAL INTELLIGENCE TRACKER CLAMP, IT WAS ENSURED THAT THE CLAMPS WERE TIGHTENED DOWN. HOWEVER, WHEN THEY WERE GOING TO CUT THE TIBIA AND CHECKING THEIR CHECKPOINTS, IT WAS RECEIVED AN ERROR THAT THE TIBIA ARRAY HAD MOVED TRIED TO VERIFY CHECKPOINTS AND IT DID NOT ALLOW TO PROCEED. THEY HAD TO RESTART THE CASE THEN IT WAS NOTICED THAT THE TIBIAL TRACKING ARRAY WAS LOOSE. THE DEVICE WAS RETIGHTENED PROCEEDED WITH THE CASE AS NORMAL CAUSING A MINIMAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149278 ↗
• InjuryOct 5, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE DOING THE CHECK POINT VERIFICATION STEP FOLLOWING THE PLANNING SCREEN, THE SYSTEM PRODUCED AN ERROR MESSAGE THAT A REAL INTELLIGENCE TRACKER CLAMP HAD MOVED. THEY RESTARTED THE CASE AND ATTEMPTED TO TIGHTEN THE CLAMPS AGAIN. AFTER THE SECOND ATTEMPT AT REGISTRATION AND PLANNING, THE SYSTEM PRODUCED A MESSAGE THAT THE TRACKER FRAME HAD MOVED AGAIN. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, USING MANUAL INSTRUMENTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877543 ↗
• InjuryOct 5, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE DOING THE CHECK POINT VERIFICATION STEP FOLLOWING THE PLANNING SCREEN, THE SYSTEM PRODUCED AN ERROR MESSAGE THAT A REAL INTELLIGENCE TRACKER CLAMP HAD MOVED. THEY RESTARTED THE CASE AND ATTEMPTED TO TIGHTEN THE CLAMPS AGAIN. AFTER THE SECOND ATTEMPT AT REGISTRATION AND PLANNING, THE SYSTEM PRODUCED A MESSAGE THAT THE TRACKER FRAME HAD MOVED AGAIN. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, USING MANUAL INSTRUMENTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877541 ↗
• InjuryOct 2, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, DURING POINT CALIBRATIONS, TWO (2) REAL INTELLIGENCE TRACKER CLAMP BECAME LOOSE. THE CLAMP WAS THEN RE-TIGHTENED, HOWEVER, CAME LOOSE AGAIN LATER IN PROCEDURE. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, USING MANUAL INSTRUMENTATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852302 ↗
• MalfunctionOct 2, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, IN THE CHECKPOINT VERIFICATION STEP FOLLOWING PLANNING, THEY RECEIVED AN ERROR THAT TWO (2) REAL INTELLIGENCE TRACKER CLAMP HAD MOVED ON BOTH, THE FEMUR AND TIBIA. AFTER STARTING OVER AND TIGHTENING THE CLAMPS A SECOND TIME, THE REMAINDER OF THE CASE WAS UNREMARKABLE, AND IT WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO HARM WAS DONE TO THE PATIENT. FOLLOWING THE CASE, WHILE REMOVING THE CLAMPS, THE SURGEON NOTED THAT THE CLAMPS WERE EASY TO REMOVE/LOOSEN BY HAND, WHICH IS TYPICALLY UNCOMMON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852182 ↗
• MalfunctionOct 2, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, IN THE CHECKPOINT VERIFICATION STEP FOLLOWING PLANNING, THEY RECEIVED AN ERROR THAT TWO (2) REAL INTELLIGENCE TRACKER CLAMP HAD MOVED ON BOTH, THE FEMUR AND TIBIA. AFTER STARTING OVER AND TIGHTENING THE CLAMPS A SECOND TIME, THE REMAINDER OF THE CASE WAS UNREMARKABLE, AND IT WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO HARM WAS DONE TO THE PATIENT. FOLLOWING THE CASE, WHILE REMOVING THE CLAMPS, THE SURGEON NOTED THAT THE CLAMPS WERE EASY TO REMOVE/LOOSEN BY HAND, WHICH IS TYPICALLY UNCOMMON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852157 ↗
• InjuryMar 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, BEFORE STARTING THE CASE, THEY TIGHTENED THE TRACKER CLAMP DOWN WITH THE CORRECT TOOL. HOWEVER, DURING A CORI TKA XR PROCEDURE, THE TRACKER CLAMP SLID ON THE TIBIAL BONE PINS WHEN CUTTING THE FEMUR. IT IS UNKNOWN WHICH OF THE TWO WERE FAULTY. THEY CHANGED TO MANUAL INSTRUMENTATION FOR TIBIA CUTTING. THERE WAS A DELAY GREATER THAN 30 MIN. THE PATIENT CARE WAS NOT COMPROMISED. NO OTHER COMPLICATIONS WERE REPORTED. SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515650 ↗