VELYS 4515-70-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295519072), received between Jan 21, 2022 and Aug 21, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6), 2025. THE SURGEON HAD COMPLETED ALL OF THE FEMUR CUTS, AND AT THE TIBIAL CUT, THE POSITION OF THE CHECKPOINT WAS NOT ACCURATE AND THEY SUSPECT THE TIBIAL ARRAY HAD MOVED. REMAINING CUTS WERE PERFORMED MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864040 ↗
• MalfunctionJul 1, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED DURING THE CASE, WHEN THE SURGEON WAS CUTTING THE TIBIA TRANSVERSE CUT, THE TRACKER MOVED; THE PROBLEM WAS WITH THE TRACKER INSERTION. THE SURGEON MANAGED TO FINISH THE CASE CORRECTLY WITHOUT SWITCHING TO MANUAL MODE.

  Patient problems: Insufficient Information

  MAUDE report 22372400 ↗
• MalfunctionAug 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SYSTEM FEELS LOOSE. WHEN ATTEMPTED A SECOND PASS ON THE DISTAL FEMUR CUT, THE INCISION WAS 3MM OFF. THEY USED ADDITIONAL CEMENT ON THE MEDIAL CONDYLE SIDE SO THERE WAS NO NEGATIVE PATIENT IMPACT. THEY ARE REQUESTING TO HAVE THE UNIT SERVICED DUE TO THE LOOSE FEELING. THEY NOTICED THAT THE TIBIAL ARRAY POPPED OUT OF THE CLAMP DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038530 ↗
• MalfunctionAug 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SYSTEM FEELS LOOSE. WHEN ATTEMPTED A SECOND PASS ON THE DISTAL FEMUR CUT, THE INCISION WAS 3MM OFF. THEY USED ADDITIONAL CEMENT ON THE MEDIAL CONDYLE SIDE SO THERE WAS NO NEGATIVE PATIENT IMPACT. THEY ARE REQUESTING TO HAVE THE UNIT SERVICED DUE TO THE LOOSE FEELING. THEY NOTICED THAT THE TIBIAL ARRAY POPPED OUT OF THE CLAMP DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038529 ↗
• MalfunctionApr 5, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ARRAY CAME LOOSE ON VELYS SAW DURING TIBIA CUT, AND SWUNG OUT. NURSE MAY NOT HAVE CLICKED IT IN PROPERLY AND MISSED BY REP AND SURGEON. TIBIA RESECTION MOSTLY WITHIN PLAN, HOWEVER POSTERIOLATER TIBIA WAS OVER RESECTED (ACCORDING TO VELYS BY 2-3MM) RECALIBRATED SAW AND SAW BLADE. REST OF CASE COMPLETED SUCCESSFULLY, ALL 4 FEMUR CUTS ACCURATE. PLANNED TO USE CEMENTLESS TIBIA - HOWEVER USED CEMENTED IMPLANTS INSTEAD BECAUSE OF INACCURATE CUT SURGERY DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049123 ↗
• MalfunctionSep 21, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ANTERIOR CHAMFER CUT LOOKED TOO LARGE SO WE HAD THE PROBE RUN ALONG THAT ONE FIRST, WHICH READ ACCURATE,. THEN I HAD HIM RUN IT OVER THE DISTAL CUT WHICH WAS OFF AND THEN MOVED TO THE CHECKPOINT WHICH WAS ALSO OFF. WAS PLANNED FOR A CEMENTLESS BUT SWITCHED TO CEMENTED ONCE WE REALIZED THE CUTS WERE INCONSISTENT. EVEN AFTER RECUTS WITH THE ARRAY IN THE SAME POSITION THE TRIAL WAS STILL SHOWING SIGNIFICANT ANT CHAMFER GAPING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17790969 ↗
• MalfunctionJul 19, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON HAD TO BAIL TO MANUAL INSTRUMENTS BECAUSE THE ARRAY POPPED OUT OF THE ARRAY CLAMPS AT SOME POINT DURING THE PROCEDURE, CAUSING STEP CUTS ON THE ANTERIOR CUT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17352324 ↗
• MalfunctionMay 19, 2022Unintended Movement; Unintended Movement

  PROBLEM REPORTED: RSS REPORTS THAT THE SURGEON HAD TO BAIL ON A CASE DUE TO A BUMPED ARRAY AND ARRAY MOVEMENT CAUSED BY THE ARRAY CLAMP WING NUT BEING LOOSE AND NOT SECURING THE ARRAY. THE SURGEON IS REQUESTING THE ARRAY CLAMP AND THE PIN INSERTER BE REPLACED AS HE BELIEVES BOTH DEVICES IMPACTED THE ARRAY MOVEMENT. THE REPORTER WAS NOT ON SITE AND RECEIVED THIS INFORMATION FROM THE SALES ASSOC. WHEN WAS THE ISSUE OBSERVED? DURING SURGERY. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? UNKNOWN. WHAT STEPS DID THE CALLER OR USER PERFORM AFTER ENCOUNTERING THIS ISSUE? BAILED TO MANUAL INSTRUMENTATION. TROUBLESHOOTING: PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? YES OR NO. ARE PATIENT TREATMENTS DELAYED OR CANCELLED? SLIGHT DELAY IN BAILING TO MANUAL, NO CANCELLATIONS. NEXT DAY OF SURGERY: (B)(6) 2022. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. IF COMPLAINT IS RELATED TO DISPOSABLE/REUSEABLES: DISPOSABLE/REUSEABLES: DETAILS HAVE BEEN EMAILED TO THE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433879 ↗
• MalfunctionMay 13, 2022Unintended Movement; Unintended Movement

  PROBLEM REPORTED: IT WAS REPORTED BY THE DOCTOR THAT THE DEVICE ARRAY IS MOVING BETWEEN 4-5MM. THEY CHECKED THE ARRAY AND IT WAS SEATED CORRECTLY IN THE RASI. WHEN WAS THE ISSUE OBSERVED? DURING SURGERY. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? UNKNOWN. WHAT STEPS DID THE CALLER OR USER PERFORM AFTER ENCOUNTERING THIS ISSUE? CHECKED TO CONFIRM PROPER INSERTION INTO THE RASI. TROUBLESHOOTING: CHECKED TO CONFIRM PROPER INSERTION INTO THE RASI. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO. ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO. NEXT DAY OF SURGERY: UNKNOWN, NO SET SCHEDULE AT THIS TIME. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14396241 ↗
• MalfunctionMay 12, 2022Unintended Movement; Unintended Movement

  PROBLEM REPORTED: (B)(6) CALLED TO REPORT THAT DURING THE DISTAL FEMUR CUT, THE SAW WAS STUTTERING. THEY CHECKED THE SAW ARRAY AND IT WAS VERY LOOSE AND IT LOOKED TO HAVE MOVED. THEY CHECKED AND CONFIRMED THAT THE ARRAY WAS FULLY SEATED AND CLAMPED CORRECTLY. THEY WERE ABLE TO COMPLETE THE SURGERY WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. THEY HAVE DISPOSED OF THE ARRAY SET SO HE DOES NOT HAVE THE LOT INFORMATION NOR THE ARRAYS TO SEND BACK FOR REVIEW. WHEN WAS THE ISSUE OBSERVED? DURING SURGERY. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? DISTAL FEMORAL CUT. WHAT STEPS DID THE CALLER OR USER PERFORM AFTER ENCOUNTERING THIS ISSUE? THEY WERE ABLE TO COMPLETE THE SURGERY USING THE ROBOT. TROUBLESHOOTING: THEY CHECKED AND CONFIRMED THE SAW ARRAY WAS FULLY SEATED ON THE SAW. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO. ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO. NEXT DAY OF SURGERY: UNKNOWN. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14373634 ↗
• MalfunctionApr 14, 2022Unintended Movement; Unintended Movement

  PROBLEM REPORTED: IT WAS REPORTED THAT THE FEMUR ARRAY MOVED DURING SURGERY AND THE CHECKPOINT WAS OFF BY 2MM. RE-REGISTERED PATIENT AND CONTINUED WITH CASE. THE ACCUBALANCE GRAPH WAS OFF WITH A 13-14 EXTENSION AND 9-12 FLEXION. ALSO, DOCTOR MENTIONED THE DISTAL RESECTION PORTION OF SURGERY THAT THE CUTS WERE NOT AS SMOOTH AS HE WOULD LIKE AND STILL FEELS LIKE SYSTEM STUTTERS. FSE REQUESTED TO PULL LOGS AND PERFORM A SYSTEM CHECKOUT. WHEN WAS THE ISSUE OBSERVED: DURING SURGERY , TROUBLESHOOTING: N/A, PATIENT INVOLVEMENT? YES, WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO, NEXT DAY OF SURGERY: UNKNOWN. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110766 ↗
• MalfunctionApr 5, 2022Unintended Movement; Unintended Movement

  PROBLEM REPORTED: CUSTOMER REPORTED BUMPING THE ARRAY AND THAT THEY CAUGHT THIS ISSUE PRIOR TO STARTING CUTS ON THE FEMUR. THE SURGEON STARTED TIBIA FIRST WORK FLOW SAW THE BUMPED ARRAY AND THEY WERE NOT ABLE TO GO BACK TO REGISTER TO START FEMUR FIRST INSTEAD. SURGEON REPORTED THAT IT IS IMPORTANT TO BE ABLE TO GO BACK AND ADJUST THE BONE AND WHAT IS SELECTED. WHEN WAS THE ISSUE OBSERVED: DURING SURGERY . TROUBLESHOOTING: THE CYLINDER THAT ALLOWS THE ARRAY TO SPIN MAKES CONTACT WITH THE WING THAT TURNS AS THEY TIGHTEN THE CLAMP AGAINST THE PINS. LOOKS LIKE A TRAPEZOID. THE LITTLE ELBOW LEVERS ON THE CYLINDER THAT HOLDS THE ARRAY. BECOMES A HUGE ISSUE WHILE TRYING TO UTILIZE A HIGH TORQUE SAW IT STARTS TO CAUSE THE PIN TO MOVE A LITTLE BIT AND THE WING NUT AND THEN THE ARRAY CLICKS. THE ARRAY MOVES APPROXIMATELY 2MM OF TRAVEL ALTHOUGH IT LOOKS TO ONLY HAVE 1MM OF PLAY. DUE TO THIS THE SURGEON DETERMINED THAT THE DISTAL AND ANTERIOR CUT WOULD BE ACCEPTABLE. THE POSTERIOR CUT WAS GOING TO BE OFF AND NOT WITHIN ACCEPTABLE RANGE. SLIGHTLY OFF AT EXIT POINT FOR ANTERIOR CUT. INTERNAL ROTATION. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013407 ↗
• MalfunctionMar 17, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  PROBLEM REPORTED: RSS REPORTS THAT THE POINTER LIFTED UP DURING THE POSTERIOR LATERAL CONDYLE REGISTRATION AND THE DOCTOR CHOSE TO PROCEED. AFTER CUTS, THE RESULT WAS THAT THE KNEE WAS TOO LOOSE MEDICALLY AND A LATERAL RELEASE WAS REQUIRED TO ALIGN THE KNEE. THIS WAS A VARUS KNEE AND NOTED BY THE REPORTER THAT THE KNEE SHOULD HAVE BEEN TIGHTER. WHEN WAS THE ISSUE OBSERVED? DURING SURGERY. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? REGISTRATION AND POST OPERATIVE MEASUREMENTS. WHAT STEPS DID THE CALLER OR USER PERFORM AFTER ENCOUNTERING THIS ISSUE? RSS ADVISED REGISTERING THE POINT AGAIN, BUT DOCTOR CHOSE TO PROCEED. THIS WAS THE DOCTOR'S 6TH CASE. TROUBLESHOOTING: RSS WOULD LIKE TO HAVE LOG FILES PULLED SO THAT HE CAN GO THROUGH THEM WITH THE DOCTOR FOR TRAINING PURPOSES. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO. ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO DELAYS, NO CANCELLED CASES. NEXT DAY OF SURGERY: UNKNOWN. NO CASES PLANNED NEXT WEEK. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13800749 ↗
• MalfunctionJan 21, 2022Unintended Movement; Unintended Movement

  PROBLEM REPORTED: BAILED CASE. TIBIAL ARRAY MOVED DURING RESECTIONS. CAUSED SOFTWARE TO SHIFT AND COULDN'T RECOVER. SYSTEM DETERMINED THAT THE KNEE MOVED EXCESSIVELY BECAUSE THE ARRAY MOVED. THIS DEFECT WAS NOTICED DURING PRE OP SET UP, NOT DURING INTRA OP RESECTIONS. NO ISSUE WITH SYSTEM OR HARDWARE. WHEN WAS THE ISSUE OBSERVED: PRE-OP TROUBLESHOOTING: SURGERY HAD TO GO TO A MANUAL SURGERY. REPORTER CHECKED SYSTEM VIA CHECKPOINTS AND WERE SHOWN TO BE VISUALLY OFF. REPORTER REPORTED THAT MOVEMENT IN THE ARRAY CAUSED THE ISSUE. PATIENT INVOLVEMENT? NO. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO. NEXT DAY OF SURGERY: UNKNOWN. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315324 ↗