VELYS 4515-70-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295519515), received between Apr 6, 2022 and Mar 3, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 11, 2022Class IITerminated

   System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment

   Z-1029-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Computer Software Problem; Use of Device Problem; Device Sensing Problem

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VELYS SATELLITE STATION DEVICE, THE VELYS BASE STATION DEVICE AND THE VELYS ARRAY SET KNEE DEVICE, THE POSTERIOR LATERAL FEMORAL CUT STATED THAT THEY WERE CUTTING 8MM BUT IT LOOKED AROUND 2MM. THEY HAD TO FINISH THE PROCEDURE USING MANUAL INSTRUMENTATION. IT WAS FURTHER OBSERVED THAT THE CAMERA WAS INTERMITTENTLY SEEING THE ARRAYS. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499932 ↗
• MalfunctionMar 3, 2026Device Reprocessing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THERE WAS FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION ON THE CAMERA LENS OF THE ROBOTIC-ASSISTED BASE STATION DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT THE CAMERA WAS INTERMITTENTLY SEEING THE ARRAYS DURING TOTAL KNEE ARTHROPLASTY (TKA). IT WAS REPORTED THAT THE USER CHECKED THE ARRAYS TO MAKE SURE THEY WERE NOT OVERLAPPING. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT AND NUMBER OF OCCURRENCES WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498684 ↗
• MalfunctionJan 16, 2026Material Fragmentation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ARRAY CLAMP DEVICE THE BROKEN CLAMP WOULD NOT TIGHTEN. A NEW CLAMP WAS OPENED TO COMPLETE THE CASE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092277 ↗
• MalfunctionAug 15, 2025Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE ROBOTIC ASSISTED BASE STATION DEVICE, THE POWER LAMP WAS NOT ON, AND THE POWER FAILED TO LATCH ON INTERMITTENTLY. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814047 ↗
• MalfunctionJun 16, 2025Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED BASE STATION DEVICE, WHILE BEING USED WITH A SATELLITE STATION DEVICE HAD THE WRONG ANTERIOR FEMUR CUT. THE LATERAL FEMUR SIDE IN AP-DIMENSION WAS PERFORMED AS PLANNED (FOR FEMUR SIZE 6 MEDIAL SIDE AP DIMENSION WAS -2.5 MM (ALMOST SUITABLE FOR SIZE 5 FEMUR). AS CONSEQUENCE THE IMPLANT DID NOT PERFECTLY FIT. IT WAS NOT POSSIBLE TO IMPLANT A CEMENT LESS FEMUR AS PLANNED WHICH WAS SWITCHED TO A CEMENTED ONE. ALL THE OTHER CUTS WERE PERFORMED CORRECTLY, CHECKED WITH POINTER, IMPLANT TRIAL AND IMPLANT. THE CASE WAS DELAYED BY 30 MINUTES. DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS FOUND THAT THE DEVICE HAD AN INACCURATE MEASUREMENT OF THE ARRAY POSITION/ORIENTATION TO THE CAMERA SYSTEM. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214561 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE A CUT WAS MADE "THAT WAS NOT APPROPRIATE". IT WAS REPORTED THAT WHILE PLACING THE IMPLANT THE ANTERIOR CUT WAS OFF. IT WAS REPORTED THAT A REVISION HAD TO BE MADE TO THE IMPLANT AND THE CONDYLE WAS FRACTURED DURING THE CASE. IT WAS REPORTED THAT THE POINTER HAD NOT BEEN USED FOR VERIFICATION. IT WAS REPORTED THAT THE CUT ON THE FEMUR HAD NOTCHED THE ANTERIOR CORTEX. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Limb Fracture; Unspecified Tissue Injury

  MAUDE report 20453078 ↗
• MalfunctionApr 19, 2024Device Reprocessing Problem; Device Sensing Problem; Device Reprocessing Problem; Device Sensing Problem

  IT WAS REPORTED FROM AUSTRALIA THAT THE ROBOTIC ASSISTED BASE STATION DEVICE POINTER/SAW VERIFICATION FAILED. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD DIRTY RESIDUE/SMEARING ON THE CAMERA LENSES AND HENCE CLEANED THE LENS. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142205 ↗
• MalfunctionJul 26, 2023Electrical /Electronic Property Problem; Connection Problem; Difficult or Delayed Separation; Electrical /Electronic Property Problem; Connection Problem; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED BASE STATION POWER CORD HAD COME OFF TWO TIMES WHERE IT LOST POWER DURING THE CASE AND WENT STRAIGHT TO DARK SCREEN. IT WAS REPORTED THAT THE POWER CORD DID NOT LOCK IN PLACE AND THAT THERE MAY HAVE BEEN ARCHING FROM THE CONNECTION TO THE CONSOLE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396088 ↗
• MalfunctionApr 20, 2023Break; Electrical /Electronic Property Problem; Break; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION BASE STATION, THE FOOT PEDAL CORD WAS "SHORTING OUT". IT WAS WORKING INTERMITTENTLY AND ERRATICALLY CAUSING THE SOFTWARE TO MOVE BACK AND FORTH THROUGH SCREENS. IT WAS REPORTED THAT THIS ISSUE OCCURRED DURING POINTER ACQUISITIONS. IT WAS REPORTED THAT MOVING THE CORD WHEN THE FOOT PEDAL WASN'T ACTIVATING AFFECTED THE OPERATION. HOLDING THE CORD CAUSED IT TO BEHAVE ERRATICALLY. IT WAS REPORTED THAT THE CASE WENT TO MANUAL INSTRUMENTATION. THERE WERE A SLIGHT DELAY IN THE CASE IN ORDER TO SWITCH TO MANUAL INSTRUMENTATION. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775630 ↗
• MalfunctionApr 6, 2022Break; Electrical /Electronic Property Problem; Break; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ROBOT ASSISTED BASE STATION DEVICE HAD AN ELECTRICAL SHORT IN THE CABLE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024541 ↗