VELYS 4515-70-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 324 adverse event reports that list this exact device (DI 10603295519492), received between Dec 8, 2021 and Sep 29, 2026 — classified as 4 injuries, 320 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (245 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 25 most recent of 324 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50937326 ↗
• MalfunctionSep 29, 2026Use of Device Problem; Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50937053 ↗
• MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50913935 ↗
• MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, when using the Robotic Assisted Satellite Station Device and the Robotic Assisted Base Station Device it was observed that the flexion gaps (medial distal condyle) was not lining up with what the surgeon was seeing and feeling in the patient anatomy. After re-registering, they went back into the Accubalance graph, went through the range of motion with the knee, and the flexion gaps increased medially and laterally. They went through the range of motion three more times, and the surgeon was still not seeing satisfactory measurements. They then re-registered points, remeasured the center of the tibia, posterior/distal condyle, and anterior aspect of femur. The surgeon then proceeded back to the Accubalance graph and was able to get measurements that lined up with the patient¿s anatomy. After this, they moved forward to resections and made them with machine size 9 settings, but they noticed the trial did not meet resections. It was reported that the Size 9 was much larger than the resections. The surgeon then chose the size 8 trial for a better fit. The Posterior chamfer was too deep however, and the patie

  Patient problems: Bone Notching

  MAUDE report 50913635 ↗
• MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, when using the Robotic Assisted Satellite Station Device and the Robotic Assisted Base Station Device it was observed that the TKA cuts were not hitting the mark. It was reported that the accuracy and resections were not what the surgeon wanted. It was reported that the robot was not mounted to the surgical bed. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.

  Patient problems: Bone Notching

  MAUDE report 50913532 ↗
• MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50903250 ↗
• MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50903148 ↗
• MalfunctionSep 25, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50902476 ↗
• MalfunctionSep 21, 2026Malposition of Device

  It was reported that during a Total Knee Arthroplasty surgery, the blade of the Robotic-Assisted Solution Satellite Station device dug into the anterior cortex during anterior resection. The device was operated in conjunction with the Robotic-Assisted Solution Base Station device. There were no delays to the surgical procedure. It was not reported if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: Bone Notching

  MAUDE report 50841900 ↗
• MalfunctionSep 17, 2026Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50808375 ↗
• MalfunctionSep 16, 2026Use of Device Problem; Malposition of Device

  Patient problems: Bone Notching

  MAUDE report 50786008 ↗
• MalfunctionSep 10, 2026Malposition of Device

  During in-house engineering evaluation, it was determined that the Robotic-Assisted Solution Satellite Station device had inaccurate cuts- greater than 3mm or unknown. It was initially reported that during a Knee surgery, the tibia was cut, the tensor was used, and femur cuts were planned. The team executed distal, anterior, posterior, and posterior chamfer cuts. Before the anterior chamfer cut, the saw plane did not look accurate. When the checkpoint was checked, it was off by more than 3mm. The device was operated in conjunction with the Robotic-Assisted Solution Base Station device. There was patient involvement. There were no injuries, no medical intervention, and no prolonged hospitalization. Patient treatments were not delayed or cancelled. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714550 ↗
• MalfunctionAug 31, 2026Improper or Incorrect Procedure or Method; Malposition of Device; Complete Loss of Power

  Patient problems: Bone Notching

  MAUDE report 50530443 ↗
• MalfunctionJun 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ACETABULAR CUP WAS BONDED/ THREADED TO THE HANDLE AND WOULD NOT SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410842 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE OFF THE FEMUR TRIAL. THE TAB BROKE OFF THE SPACER BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364116 ↗
• MalfunctionMay 12, 2026Malposition of Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VELYS SATELLITE STATION DEVICE SATELLITE STATION : INACCURATE CUTS- GREATER THAN 3MM OR UNKNOWN. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE FLEXION GAP WAS ABNORMALLY TIGHT. THE FEMORAL ARRAY WAS MOVED WHICH CAUSED ALL FEMORAL CUTS BEING POSTERIORIZED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 25149475 ↗
• MalfunctionMar 31, 2026Malposition of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE VELYS SATELLITE STATION DEVICE MULTIPLE CUTS WERE OFF. 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: Bone Notching

  MAUDE report 24742602 ↗
• MalfunctionMar 31, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE VELYS SATELLITE STATION DEVICE, THE CUTS WERE OFF WHILE IN USE WITH THE VELYS BASE STATION DEVICE. 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: Bone Notching

  MAUDE report 24741913 ↗
• MalfunctionMar 26, 2026Improper or Incorrect Procedure or Method; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, WHILE USING THE ROBOTIC ASSISTED SATELLITE STATION DEVICE AND THE ROBOTIC ASSISTED BASE STATION DEVICE IT WAS OBSERVED THAT THE TIBIA CUT WAS 3MM DISTAL TO EXPECTED PLAN. IT WAS REPORTED THAT THERE WAS NOTHING UNORDINARY DURING THE PROCEDURE. IT WAS REPORTED THAT THE ROBOT WAS NOT MOUNTED TO THE SURGICAL BED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703689 ↗
• MalfunctionMar 24, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Malposition of Device

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, WHILE USING THE ROBOTIC ASSISTED SATELLITE STATION DEVICE WITH THE ROBOTIC ASSISTED BASE STATION DEVICE, IT WAS OBSERVED THAT THE DISTAL FEMUR CUT WAS GOOD, BUT THE ANTERIOR CUT WAS VISUALLY CONFIRMED TO BE OFF, ABOUT 7MM MORE POSTERIOR THAN IT SHOULD BE. IT WAS REPORTED THAT IT WAS SO NOTICEABLY OFF TO WHERE THE RESECTIONS WERE COMPLETED MANUALLY. THE SURGEON MOVED TO POSTERIOR CUT TO VERIFY, AND THE SAW BLADE WAS NOT CUTTING BONE WHEN IT WAS SUPPOSED TO CUT 7MM. THE SURGEON DOWNSIZED THE FEMUR FROM 5 TO 4 WITH MANUAL CUTTING BLOCKS USING ANGEL WING AS REFERENCE ON ANTERIOR CUT. FINAL TRIAL NUMBERS WERE WAY OFF. CEMENTED IMPLANTS PLANNED AND USED.

  Patient problems: Bone Notching

  MAUDE report 24673740 ↗
• MalfunctionMar 23, 2026Use of Device Problem; Malposition of Device

  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 SAW HANDPIECE DEVICE THE ANTERIOR CHAMFER CUT THE SAW ARRAY BECAME LOOSE AND SWUNG OFF. SURGEON THEN PUT IT BACK ON AND ALLOWED HIS FELLOW TO FINISH THE CUT. THE DEVICE WAS IN USE WITH THE VELYS BASE STATION DEVICE AND THE VELYS SATELLITE STATION DEVICE. 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: Bone Notching

  MAUDE report 24670224 ↗
• MalfunctionMar 20, 2026Use of Device Problem; Positioning Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, WHILE USING THE ROBOTIC ASSISTED SATELLITE STATION DEVICE AND THE ROBOTIC ASSISTED BASE STATION DEVICE IT WAS OBSERVED THAT THE DISTAL CUT WAS RATHER THIN. IT WAS REPORTED THAT THE SURGEON DID NOT MAKE THE CUT AND BAILED TO MANUAL DEVICES. IT WAS REPORTED THAT THE ROBOT WAS MOUNTED TO THE SURGICAL BED. DURING REVIEW OF THE DEVICE EVENT LOG, IT WAS FOUND THAT THERE WAS APPROXIMATELY 1.6MM INACCURACY IN THE DISTAL CUT. IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652486 ↗
• MalfunctionMar 19, 2026Use of Device Problem; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, WHILE USING THE ROBOTIC ASSISTED SATELLITE STATION DEVICE AND THE ROBOTIC ASSISTED BASE STATION DEVICE IT WAS OBSERVED THAT THE TIBIA CUT WAS EXCESSIVELY LARGE. SURGEON DID NOT MAKE THE CUT AND BAILED TO MANUAL DEVICES. IT WAS REPORTED THAT THE ROBOT WAS MOUNTED TO THE SURGICAL BED. DURING REVIEW OF THE DEVICE EVENT LOG IT WAS FOUND THAT THERE WAS APPROXIMATELY -16.3 MM INACCURACY IN THE TIBIAL CUT. IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641240 ↗
• MalfunctionMar 19, 2026Device Alarm System; Use of Device Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, WHILE USING THE ROBOTIC ASSISTED SATELLITE STATION DEVICE, ROBOTIC ASSISTED BASE STATION DEVICE, AND THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE TO MAKE CUTS, IT WAS OBSERVED THAT 2 CUTS HAD A 1-2MM VARIANCE. IT WAS REPORTED THAT THE SURGEON TRIED PROGRESSING TO ANOTHER CUT, HOWEVER THE SYSTEM GAVE EXCESSIVE DISTAL PLANE MOVEMENT ERRORS. IT IS UNKNOWN IF THE ROBOT WAS MOUNTED TO THE SURGICAL BED. IT WAS REPORTED THAT MANUAL TOOLS WERE USED TO CONTINUE THE PROCEDURE. DURING REVIEW OF THE DEVICE EVENT LOG IT WAS FOUND THAT THERE WAS APPROXIMATELY A 1.8MM INACCURACY OF THE ANTERIOR CHAMFER CUT AND 3.2MM INACCURACY OF THE POSTERIOR CUT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638807 ↗
• MalfunctionMar 5, 2026Malposition of Device

  IT WAS REPORTED THAT WHEN CONVERTING FROM AN UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) SURGICAL PROCEDURE TO A TOTAL KNEE SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE VELYS SATELLITE STATION DEVICE AND THE VELYS BASE STATION DEVICE, DURING THE FIRST FEMUR CASE THE USER COMPLETED CUTS ON THE NON INVOLVED SIDE, THEN CHISELED OUT THE PROSTHESIS FOR THE SECOND ROUND OF CUTS WITH THE ROBOT. THE SECOND ROUND OF FEMORAL CUT PLANES WERE OFF BY APPROX. 4MM BUT THE FEMORAL CHECKPOINT MEASURE ZERO. THE DISTAL CUTS WERE FINE. 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: Bone Notching

  MAUDE report 24525114 ↗