VISIONAIRE V0100109Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00885556656396), received between Jun 28, 2019 and Mar 30, 2026 — classified as 29 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE CUTS WERE MADE USING A VIS ADPT GUIDE LGNP KIT. ON THE TRIAL OF THE CRUCIATE RETAINING (CR) FEMORAL COMPONENT, IT APPEARED TO BE IN EXCESSIVE EXTERNAL ROTATION. IN EXTENSION, ALIGNMENT WAS FINE, BUT IN FLEXION IT OPENED MEDIALLY. IN ORDER TO ACHIEVE A BALANCED KNEE, THE POSTERIOR CRUCIATE LIGAMENT (PCL) HAD TO BE RESECTED, AND THE CR KNEE CONVERTED TO A POSTERIOR STABILIZED (PS) KNEE. AN ADDITIONAL BONE RESECTION WAS REQUIRED AS WELL. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 24736966 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT LEGION CR VISIONAIRE SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT'S LEG REMAINED IN A VALGUS POSITION AFTER THE SURGERY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) GNS II CMT TIB SIZE 6 {} LEFT WAS EXPLANTED, AN AXIS- CORRECTION WAS PERFORMED AND A LEGION TIBIAL IMPLANT WITH LONGSTEM WAS IMPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24353442 ↗
• InjuryDec 3, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKR, ONE (1) VIS ADPT GUIDE LGNP KIT DID NOT FIT THE FEMUR. IT WAS DECIDED AT THE TIME THAT IT CLOSE TO PROCEED. HOWEVER, THE DISTAL PINS FOR FEMORAL ROTATION FORCED FEMUR INTO EXTRA EXTERNAL ROTATION. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, AS THE SURGEON HAD TO PROCEED TO POSTERIOR STABILIZED TECHNIQUE INSTEAD OF CRUCIATE RETAINING. AS A RESULT, THE POSTERIOR CRUCIATE LIGAMENT WAS REMOVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23702834 ↗
• MalfunctionSep 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE BLOCKS OF ONE (1) VIS ADPT GUIDE LGNP KIT DID NOT FIT APPROPRIATELY; CUTS WERE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE TO INSTRUMENTED TECHNIQUE AND USING A 15MM POLY INSTEAD OF 9-10MM. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 23163853 ↗
• MalfunctionDec 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE SURGEON HAD A VERY THICK TIBIAL CUT WITH ONE (1) VIS ADPT GUIDE LGNP KIT AND HAD TO USE A 15 MM INSERT. THE SURGEON HAD TO ABORT THE TIBIAL BLOCK, AND CUT THE TIBIA WITH STANDARDS INSTRUMENTS, SINCE THE PLAN SHOWED A VERY THICK PICTURE OF THE TIBIAL CUTS. THE PROCEDURE WAS RESUMED WITH A CHANGE IN THE SURGICAL TECHNIQUE. IT IS UNKNOWN IF THE EVENT CAUSED ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 21030842 ↗
• MalfunctionDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, ON CASE, THE CUTS PERFORMED WITH THE WERE VIS ADPT GUIDE LGNP KIT WAS TOO THICK, AND HAD TO USE A 15MM INSERT. DOCTOR HAD TO ABORT THE TIBIAL BLOCK AND CUT THE TIBIA WITH STANDARD INSTRUMENTS. PLANS SHOWED A VERY THICK PICTURE OF THE TIBIAL CUTS. IT IS UNKNOWN IF A DELAY WAS REPORTED OR IF THIS CAUSED ANY INJURY TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 21018663 ↗
• MalfunctionDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, ON CASE # (B)(4), THE VIS ADPT GUIDE LGNP KIT WAS TOO THICK. DOCTOR HAD TO ABORT THE TIBIAL BLOCK AND CUT THE TIBIA WITH STANDARD INSTRUMENTS. PLANS SHOWED A VERY THICK PICTURE OF THE TIBIAL CUTS. IT IS UNKNOWN IF A DELAY WAS REPORTED OR IF THIS CAUSED ANY INJURY TO THE PATIENT.

  Patient problems: Laceration(s)

  MAUDE report 21018656 ↗
• MalfunctionApr 22, 2024Positioning Failure; Inadequacy of Device Shape and/or Size; Positioning Failure; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) VIS ADPT GUIDE LGNP KIT DID NOT FIT ON EITHER THE FEMUR OR THE TIBIA SIDE, AND THERE WAS AN EDGE OF ROUGHLY 2MM ON THE ANTERIOR CUT OF THE FEMUR. BOTH THE FEMUR AND THE TIBIA IMPLANTS HAD TO BE DOWNSIZED TO SIZE 6; HENCE, NO ADDITIONAL BONE CUT WERE PERFORMED. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY BY SWITCHING TO STANDARD INSTRUMENTATION. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19151906 ↗
• InjuryMar 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE USING A VIS ADPT GUIDE LGNP KIT, IT WAS NEEDED TO RECUT THE DISTAL FEMUR ANOTHER 2 MM AS WELL AS RECUT THE PROXIMAL TIBIA ANOTHER 4 MM TO ACHIEVE AN 11MM POLY INSERT. NO OTHER COMPLICATIONS OR DELAY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 18926935 ↗
• MalfunctionDec 22, 2023Material Fragmentation; Inadequacy of Device Shape and/or Size; Material Fragmentation; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA A VIS ADPT GUIDE LGNP KIT WAS INTRODUCED INTO THE CUTTING GUIDE IT WAS MET WITH RESISTANCE; HOWEVER, THE DOCTOR CONTINUED TO ACTIVATE THE SAW AND PRESS GENTLY THROUGH THE RESISTANCE OF THE GUIDE, EVENTUALLY CUTTING THROUGH EXCESS PLASTIC FROM THE PRINTING PROCESS. PIECES OF THE CUTTING BLOCK WERE INTRODUCED INTO THE WOUND AND ALL THE PIECES WERE THOROUGHLY REMOVED WITH FORCEPS, SUCTION AND LAVAGE. THE METAL DISTAL FEMORAL CUTTING BLOCK WAS SUBSEQUENTLY USED TO RECUT THE DISTAL FEMUR AND REVISE THE INITIAL CUT FROM THE VISIONARIES BLOCK. THE DOCTOR NOTED THAT THE VISIONARIES BLOCK WAS "NOT QUITE RIGHT", FOR WHICH HE USED THE VNR CUTTING GUIDE DURING THE FIRST DISTAL CUT, AND THEN USED THE METAL, REUSABLE DISTAL CUTTING BLOCK TO REFINE THE INITIAL CUT. THE PROCEDURE WAS COMPLETED BY PLACING THE ORIGINALLY PLANNED IMPLANTS OF THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384117 ↗
• InjurySep 7, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY USING A VIS ADPT GUIDE LGNP KIT THEY RECUT +2MM ON THE FEMUR, +2MM ON THE TIBIA, ADDED MORE SLOPE, DOWNSIZED THE FEMUR TO A 6 AND TIBIA TO A 5. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17698024 ↗
• InjuryJun 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE FEMORAL AND THE TIBIAL GUIDES FROM ONE (1) VIS ADPT GUIDE LGNP KIT, DID NOT FIT WELL ON THE PATIENT. THE SURGEON TRIED TO PLACE THE GUIDES THE BEST HE COULD DETERMINE, AND MADE THE CUTS USING THEM. HOWEVER, THE SURGEON HAD TO RECUT BOTH THE FEMUR AND TIBIA DUE TO ALIGNMENT ISSUES. THE PROCEDURE WAS RESUMED AFTER A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 17199509 ↗
• InjuryMay 24, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A FEMORAL DISTAL CUTTING BLOCK FROM A VIS ADPT GUIDE LGNP KIT CUT THE KNEE IN VALGUS. SURGEON HAD TO RECUT USING STANDARD INSTRUMENTS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Laceration(s); Unspecified Tissue Injury

  MAUDE report 16992953 ↗
• MalfunctionMar 13, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, A TKA SURGERY, THAT WAS PLANNED TO USE A RIGHT NS VIS ADPT GUIDE LGNP KIT, WAS DELAYED MORE THAN 30MIN, BECAUSE LEFT CUTTING BLOCKS, BOTH FOR FEMUR AND TIBIA WERE SUPPLIED. A CHANGE IN SURGICAL TECHNIQUE HAD TO BE MADE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527360 ↗
• InjuryFeb 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA WITH THE USE OF A VIS ADPT GUIDE LGNP KIT, THE SURGEON TOOK 8 ADDITIONAL MILLIMETERS OFF THE FEMUR. THE FINAL IMPLANTS USED WERE A SIZE 5 CRUCIATE-RETAINED FEMORAL COMPONENT, A SIZE 4 TIBIAL BASE PLATE, A 38 MM OVAL PATELLA AND A 13MM DISHED INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 16383401 ↗
• MalfunctionNov 14, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING LEFT LEG TKA SURGERY, THE SURGEON CONCLUDED THAT ONE (1) VIS ADPT GUIDE LGNP KIT WAS NOT FITTING WELL AT THE TIME THE TIBIAL BLOCK WAS PLACED. THE SURGEON NOTICED THAT THE BLOCK WOULD PUT HIM IN 10 DEGREES VARUS, SO HE RESUMED THE PROCEDURE WITHOUT SIGNIFICANT DELAY CHANGING TO A STANDARD CUTTING BLOCK. THE PROSTHESIS SIZES USED WERE THE SAME AS INITIALLY TEMPLATED. THE FINAL OUTCOME OF THE SURGERY WAS SATISFACTORY AND THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786973 ↗
• InjuryNov 5, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER PLACING THE VIS ADPT GUIDE LGNP KIT ON THE PATIENT, THE DOCTOR NOTICED THAT THE PROXIMAL CUT WAS IN APPROXIMATELY 10 DEGREES OF VALGUS. HE THEN BAILED TO TRADITIONAL INSTRUMENTATION TO COMPLETE THE SURGERY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740873 ↗
• InjuryJul 26, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHERE VISIONAIRE ADAPTIVE GUIDE KIT LEGION PRIMARY WERE USED, THE FEMORAL BLOCK CUT PATIENT IN TOO MUCH EXTENSION AND THE TIBIAL BLOCK CUT PATIENT IN TOO MUCH VARUS. SURGEON HAD TO RECUT TWICE ON FEMUR AND TIBIA TO ADJUST HIS SQUARE EXTENSION/FLEXION GAPS. IT IS UNKNOWN IF THIS CAUSED ANY DELAY TO THE PROCEDURE, AS WELL AS THE OUTCOME OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108034 ↗
• InjuryFeb 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT, WHILE USING VIS ADPT GUIDE LGNP KIT DURING A TKA, THE TIBIAL GUIDE HAD TOO MUCH VARUS BUILT IN. SURGEON HAD TO USE STANDARD INSTRUMENTATION TO MAKE PROXIMAL TIBIAL CUT. IT IS UNKNOWN HOW LONG SURGERY WAS DELAYED AS CONSEQUENCE. ON THE OTHER HAND, THE FEMORAL GUIDE WAS FINE AND RESULTED IN A GOOD CUT. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587163 ↗
• MalfunctionJan 6, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, SURGEON RECUT DISTAL FEMUR +2MM. THEN SURGEON MOVED ON TO TIBIA, WHERE HE PLACED THE TIBIA BLOCK WITH ALIGNMENT ROD. AFTER THAT, SURGEON CUT THROUGH BLOCK AND SIZED TIBIA, NOTICING ANTERIOR OVERHANG OF THE TIBIA BASEPLATE AND DECIDED TO DOWNSIZE FROM A SIZE 6 TO SIZE 5 COMPONENT. THE SURGEON FREE FLOATED THE TIBIA BASEPLATE. UPON POST OP X-RAY, SURGEON NOTED THE TIBIA IMPLANT HAD MORE SLOPE THAN PLANNED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176733 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED THAT THE VIS ADPT GUIDE LGNP KIT RESULTED IN A VARUS TIBIA RESECTION. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078483 ↗
• InjuryDec 7, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS FOUND THAT THE CUTTING GUIDES FROM A VIS ADPT GUIDE LGNP KIT WERE NOT PROPERLY MANUFACTURED. AFTER CUTS WERE MADE, THE LEG ALIGNMENT WAS OFF. THE ISSUE WAS FIXED VIA STANDARD INSTRUMENTATION, AND NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT INJURED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953519 ↗
• InjuryDec 7, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS FOUND THAT THE CUTTING GUIDES FROM A VIS ADPT GUIDE LGNP KIT WERE NOT PROPERLY MANUFACTURED. AFTER CUTS WERE MADE, THE LEG ALIGNMENT WAS OFF. THE ISSUE WAS FIXED VIA STANDARD INSTRUMENTATION, AND NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT INJURED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953486 ↗
• InjuryOct 4, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A VIS ADPT GUIDE LGNP KIT DUG INTO THE FEMUR. IT IS UNKNOWN IF THIS WAS NOTICED DURING SURGERY OR AFTER THE X-RAYS. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569288 ↗
• InjurySep 3, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIBIAL BLOCK OF A VIS ADPT GUIDE LGNP KIT DID NOT HAVE A SOLID, STABLE FIT. THE SURGEON SHIFTED THE BLOCK BACK AND FORTH AND NEVER FOUND A SPOT WHERE IT LOCKED IN OR FELT SECURE, EVEN THOUGH NO OSTEOPHYTES OR SOFT TISSUE WERE RESTRICTING IT. THE SURGEON DID NOT USE THE TIBIAL BLOCK AND REVERTED TO THE IM GUIDE. IT IS UNKNOWN IF THIS PROBLEM CAUSED A SURGICAL DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421862 ↗