REAL INTELLIGENCE ROB10012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556757314), received between Feb 17, 2021 and Oct 15, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, AFTER A CORI ASSISTED SURGERY USING HIP7 NAVIGATION PERFORMED ON (B)(6)2025, IT WAS NOTICED THROUGH AN X-RAY THAT A REAL INTELLIGENCE CHECKPOINT PINS QTY:4 WAS LEFT IN FEMUR. THE PATIENT WAS BROUGHT BACK TO THEATRE AND A REVISION SURGERY WAS PERFORMED ON (B)(6)2025 TO REMOVE IT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291352 ↗
• InjuryFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, AT THE COMPLETION OF THE CASE, THE SURGEON WENT TO REMOVE THE REAL INTELLIGENCE CHECKPOINT PINS QTY:4 FROM THE TIBIA, BUT IT BROKE OFF AT THE HEAD JUNCTION AND THE PIN WAS UNABLE TO BE REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21460491 ↗
• InjuryJun 13, 2021Break; Break

  IT WAS REPORTED THAT, ONCE THE CORI-ASSISTED TKA SURGERY WAS FINISHED, ONE REAL INTELLIGENCE CHECKPOINT PIN BROKE IN HALF WHEN IT WAS BEING PULLED OUT. THE REMAINING PART WAS PULLED OUT EASILY. THERE WERE NO DELAYS AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988913 ↗
• MalfunctionMar 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT BEFORE CORI TKA PROCEDURE, IT WAS FOUND THAT THE CHECKPOINT PIN HAD ITS END BROKEN OFF (IT WAS IN THE PIN CADDY). THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505007 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CORI TKA JOURNEY BCS PROCEDURE WHEN ADVANCED TO THE VISUALIZE PLANE SCREEN FOR THE TIBIA AS THE SURGEON WAS SETTING UP HIS JIG, THE PLANE CHECKER SHOWED SIGNIFICANT DEVIATION FROM THE PLANNED PLANES. THE SURGEON DIDN¿T TRUST IT, AND THEY WENT TO VERIFY CHECKPOINTS. THEY FAILED THE FEMUR CHECKPOINT FOUR TIMES AT 3.5MM. THEY WERE USING THE 152MM CORI BONE PINS IN THE FEMUR AND THE CLAMP WAS TIGHTENED AS HIGH AS IT COULD GO DISTAL TO THE BLACK LASER ETCH LINE. THE THIGH OF THE PATIENT WAS LARGE AND THE BONE PINS WERE PLACED ON THE ANTERIOR FEMORAL SHAFT. THEY SUGGESTED TO PLACE THEM WITHIN THE METAPHYSICS ON HIS LARGER PATIENTS, BUT HE OBJECTED THAT HE WOULD NEED TO MAKE A LARGER INCISION TO ACCOMMODATE THIS PLACEMENT. THE CASE WAS CONTINUED WITH MANUAL PROCEDURE (FINISHED THE TIBIA USING THE JIG WITHOUT CORI NAVIGATION) WITHOUT DELAYS OR ADDITIONAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447793 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE CORI TKA PROCEDURE (WHERE NO ERRORS OR ISSUES OCCURRED), THE CHECKPOINT PINS WERE NOT REMOVED PRIOR TO CLOSING THE INCISION. THE PINS WERE DETECTED ON THE POST-OP IMAGES WHILE THE PATIENT WAS STILL IN RECOVERY. THE PATIENT WAS RETURNED TO THE OPERATING ROOM, IN WHICH BOTH CHECKPOINT PINS WERE SUCCESSFULLY REMOVED VIA TWO SKIN INCISIONS AND C-ARM IMAGING.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340950 ↗