VISIONAIRE V0200112Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00885556658406), received between Apr 18, 2018 and Dec 30, 2025 — classified as 15 injuries, 14 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) NS VIS ADPT GUIDE JII KIT WAS RESECTING TOO MUCH POSTERIOR FEMUR, THE ISSUE WAS NOTICED ONLY AFTER RESECTIONS WERE MADE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A 15MM INSERT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 23922592 ↗
• MalfunctionJun 9, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY, DRILL HOLES IN THE CUTTING GUIDES DID NOT ALIGN WITH THE JNS VIS ADPT GUIDE JII KIT; THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACK-UP DEVICE AND THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168128 ↗
• MalfunctionOct 29, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR TKA CASE WAS SENT ANOTHER PATIENT INSTRUMENT WITH THE SAME LAST NAME. THE BLOCK RECEIVED WAS FOR THE WRONG PATIENT. THE OUTER BOX, LABEL AND STICKERS WERE CORRECT. UPON OPENING THE INNER STERILE PACKAGING, IT WAS DISCOVERED THE VIS ADPT GUIDE KIT JII BLOCK WAS INCORRECT. THE PROCEDURE WAS COMPLETED AFTER A SIGNIFICANT DELAY GREATER THAN 30MINS WITH MANUAL STANDARD INSTRUMENTATION AND DID NOT USE THE BLOCK. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558668 ↗
• InjuryFeb 23, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA SURGERY ONE (1) NS VIS ADPT GUIDE JII KIT SIZE SHOULD HAVE BEEN A FLEXED 5 INSTEAD OF A 6. WITH OSTEOPHYTES REMOVED, THE 6 WOULD HAVE OVERHUNG THE FEMUR BY SEVERAL MILLIMETERS. THE SIZE 6 PLANNED CUT FROM THE VISIONIARE BLOCK WAS TOO LARGE. SURGEON DOWNSIZED TO A SZ 5 TO FIT THE PATIENTS ANATOMY BETTER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 18773273 ↗
• InjuryFeb 12, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN USING A BLOCK FROM A NS VIS ADPT GUIDE JII KIT IT MADE THE SURGEON CUT TOO MUCH BONE ON THE ANTERIOR LATERAL PORTION. A DIFFERENT SIZE IMPLANT WAS USED THAN PLANNED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME KIT. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18684563 ↗
• InjuryJan 22, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY UTILIZING ONE (1) NS VIS ADPT GUIDE JII KIT, A VISIONAIRE PLAN FOR AN 8 FEMORAL AND 8 TIBIAL WAS INCORRECT. A 7 FEMORAL AND 6 TIBIAL WERE IMPLANTED. A 15MM POLY LINER WAS USED, DOCTOR FELT THE DISTAL FEM AND PROXIMAL TIBIAL CUTS WERE TOO AGGRESSIVE AND CAUSED THE BIGGER GAP IN FLEXION AND EXTENSION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 18552485 ↗
• InjurySep 5, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY, USING THE NS VIS ADPT GUIDE JII KIT, THE TIBIA RESECTION WAS PLANNED FOR 10MM ON THE HIGH SIDE BUT AFTER PUTTING THE BLOCK ON THE PATIENT AND PINNING IT IN PLACE, THE SURGEON CUT THROUGH THE METAL TIBIA CUT BLOCK BUT DID NOT CUT THROUGH THE VISIONAIRE BLOCK. THE SURGEON CUT OFF THE TOP OF THE METAL TIBIA CUT BLOCK, RATHER THAN THE CUTTING SLOT, BECAUSE THE RESECTION LOOKED TOO LARGE. A 12MM POLY WAS STILL USED. THE RESECTION AMOUNT WAS MUCH LARGER THAN WHAT THE VISIONAIRE PLAN INDICATED. IN ADDITION, THE SIZE FIVE FEMUR WAS FAR TOO BIG. THEY DID NOT TAKE ANY OF THE ANTERIOR FEMUR WITH THE SIZE FIVE CUT BLOCK, THROUGH THE ANTERIOR CUTTING SLOT. NEEDED TO DOWNSIZE TO A FOUR FEMUR IMMEDIATELY. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. PATIENT IS RECOVERING. NO FURTHER INFORMATION IS AVAILABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 17684469 ↗
• MalfunctionMay 18, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA SURGERY, IN A S VIS ADPT GUIDE JII KIT, THE FEMUR BLOCK DID NOT FIT, ANTERIOR PORTION OF THE NS VIS ADPT GUIDE JII KIT DID NOT ALIGN WITH THE NATIVE FEMUR OF THE PATIENT (ANTERIOR FEMUR WAS WAY OFF) AND HAD TO BAIL TO STANDARD INSTRUMENTATION. IT IS UNKNOWN IF THERE WAS A DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957576 ↗
• InjuryMay 13, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, BLOCKS FROM A NS VIS ADPT GUIDE JII KIT CAUSED A DISCREPANCY IN THE FLEXION/EXTENSION GAP. AFTER RESECTION, THERE WAS A 4MM GREATER GAP IN EXTENSION VS. FLEXION, TOO MUCH DISTAL FEMUR WAS TAKEN OFF. THIS WAS CLEAR WHEN THE FLEX/EXTENSION GAP BLOCK WAS PLACED INTO THE RESECTED BONE. TO OPEN THE FLEXION GAP, THE FEMUR WAS DOWNSIZED FROM AN 8 TO A 7, AND TRIALED AGAIN. AFTER TRIALING, THE FLEXION GAP WAS OPENED EVEN MORE SO A PCL WAS TAKEN OUT, AND SWITCHED TO A BCS FEMUR. A LITTLE BIT OF HYPER EXTENSION WAS NOTICED DURING TRIALING AND AFTER IMPLANTING THE FINAL COMPONENTS. IT IS UNKNOWN IF A DELAY OCCURRED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity; Laceration(s); Unspecified Tissue Injury

  MAUDE report 16926973 ↗
• MalfunctionApr 25, 2023Fracture; Positioning Problem; Fracture; Positioning Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A TIBIAL AND FEMORAL CUTTING BLOCK, FROM A NS VIS ADPT GUIDE JII KIT, DID NOT POSITION CORRECTLY ON THE PATIENT. THE TIBIA BLOCK HAD A NON-OPTIMAL FIT OVER THE MEDIAL AND LATERAL TIBIAL PLATEAU, AND THE CUTTING SLOT ALSO FRACTURED DURING RESECTION, BUT NO PIECE FELL INSIDE THE PATIENT. ON THE OTHER HAND, THE ROTATION OF THE FEMUR WAS OUT BY SEVERAL DEGREES, THIS WAS NOTICED BECAUSE A CONVENTIONAL SIZING DEVICE, TO CONFIRM ROTATION, WAS USED. THE PHYSICIAN ROTATED THE FEMUR TO THE PREFERRED POSITION AND OPTIMAL 3 DEGREES. THIS LEAD TO A NON SIGNIFICANT DELAY IN THE PROCEDURE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808624 ↗
• InjuryMar 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A NS VIS ADPT GUIDE JII KIT WAS NOTICED TO BE INACCURATE. WHEN THE CUTTING BLOCKS WERE USED, NOT ENOUGH BONE WAS REMOVED TO MATCH THE PLAN AND WAY TOO MUCH FLEXION WAS USED FOR THE DISTAL FEMORAL CUT. BOTH FEMUR AND TIBIA REQUIRED RE-CUTTING TWICE TO ACCEPT A 9MM SPACER BLOCK. THE PLAN INDICATED A FEMORAL COMPONENT SIZE 8 AND TIBIAL COMPONENT SIZE 7 WERE GOING TO BE USED, BUT THE END RESULT WAS A FEMORAL COMPONENT SIZE 6 AND TIBIAL COMPONENT SIZE 7. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM, BUT REQUIRED ADDITIONAL GENERAL ANESTHESIA TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649889 ↗
• InjuryMar 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, USING A NS VIS ADPT GUIDE JII KIT, THE PLANNED FEMORAL COMPONENT OF SIZE 7 OVERLAPPED THE FEMORAL CONDYLAR BORDER BOTH MEDIALLY AND LATERALLY, SO THAT IT WAS NECESSARY TO SWITCH TO THE NEXT SMALLER SIZE 6. THIS RESULTED IN AN INCREASE IN THE FLEXION GAP WITH ONLY MINIMAL CORRECTABLE ANTERIOR INCISION. TO RESTORE A BALANCE BETWEEN THE EXTENSION AND FLEXION GAPS, THE DISTAL FEMUR WAS RESECTED BY 2 MM WITH THE RESECTION BLOCK. CONSEQUENTLY, AN INLAY OF 11 MM HAD TO BE IMPLANTED (ORIGINALLY PLANNED 9 MM + 2 MM RESECTION, GIVEN BY THE SMALLER FEMUR). THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. PATIENT CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Perforation; Rupture

  MAUDE report 16542387 ↗
• MalfunctionMar 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA SURGERY WHEN THE TIBIA VISIONARIE BLOCK WAS PLACED, IT WAS NOTICED THAT HAD A LOT OF SLOPE IN THE CUT. THE ALIGNMENT GUIDE WAS CLOSE TO TOUCH THE TIPS OF THE TOES. THE BLOCK ITSELF FITS PERFECTLY. THE DOCTOR WAS ABLE TO USE THE STARTING HOLES FROM THE BLOCK AND USE THE STANDARD INSTRUMENTATION TO CORRECT THE SLOPE. SURGERY WAS RESUMED WITHOUT ANY DELAY. THE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479857 ↗
• InjuryNov 1, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, SURGEON NOTED THAT THE POSTERIOR CUTS DONE BY THE NS VIS ADPT GUIDE JII KIT WERE VERY LARGE MEASURING 16MM MEDIALLY AND 8MM LATERALLY FROM THE THICKEST POINTS. AFTER CUTTING, THE FEMUR LOOKED ROTATED IN FLEXION AND HAD A HUGE GAP MEDIALLY IN FLEXION. MORE DISTAL FEMUR WAS CUT TO BALANCE THE RESECTIONS AND A 18MM CONSTRAINED INSERT WAS USED AS WELL AS A SHORT STEM TIBIA. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE.

  Patient problems: Joint Laxity; Laceration(s)

  MAUDE report 15708970 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE FEMUR BLOCK PADDLE TAB FROM A VIS ADPT GUIDE KIT JII WAS BROKEN DURING SHIPMENT. AS THIS WAS NOTICED DURING THE SET-UP OF A TA SURGERY, THE PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659191 ↗
• MalfunctionApr 6, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE NS VIS ADPT GUIDE JII KIT DID NOT FIT INTO THE PATIENT. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022854 ↗
• MalfunctionApr 4, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A NS VIS ADPT GUIDE JII KIT DID NOT FIT, THE CHAMFER BLOCK WAS IN 5 TO 6° OF EXTERNAL ROTATION RATHER THAN THE 3° ACCORDING TO HIS VISIONAIRE PLAN. SURGERY WAS FINISHED AFTER USING THE AP SIZER GUIDE AND CHANGING THE ROTATION TO 3°. A DELAY OF 30 MINUTES OR LESS WAS OCCURED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996225 ↗
• MalfunctionFeb 11, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON AN UNKNOWN DATE, THE ALIGNMENT PROVIDED BY THE (B)(6).JII KIT WAS NOT OPTIMAL. THE SURGEON FELT LIKE THE ANTERIOR FLANGE OF THE IMPLANT DIVERTED OFF THE ANTERIOR FEMUR, BUT DECIDED TO GO THROUGH THE PROCEDURE ANYWAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. THE PATIENT WILL NOT NEED AN ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515712 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE KNEE OF THE PATIENT ENDED UP IN 10 DEGREES OF VALGUS. ACCORDING TO SURGEON, BOTH BLOCKS FROM NS VISIONAIRE ADAPTIVE GUIDE KIT JOURNEY II FIT WELL DURING THE PROCEDURE. THE TIBIA ALIGNMENT ROD WAS USED TO PLACE BLOCK. THE CUTS WERE MADE. ONCE THE IMPLANTS WERE CEMENTED, THE SURGEON USED ALIGNMENT RODS TO MEASURE AND NOTICED THAT THE KNEE WAS IN VALGUS. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Ecchymosis; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

  MAUDE report 13208756 ↗
• InjuryJan 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA WITH NS VIS ADPT GUIDE JII KIT, THE STAFF NEEDED TO BE TAKING A BIG CUT ON THE TIBIA 2MM, THEY WENT DOWN AT LEAST 4MM. THE DISTAL FEMUR WAS ALSO VERY MINIMAL AND THEY HAD TO TAKE AN EXTRA 2MM WITH NORMAL CUTTING BLOCK. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 13191708 ↗
• MalfunctionNov 19, 2021Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE NS VIS ADPT GUIDE JII KIT ARRIVED BROKEN OFF IN PACKAGING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848900 ↗
• MalfunctionNov 17, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, THE LABELLING OF A NS VIS ADPT GUIDE JII KIT DOES NOT MATCH WITH THE PRODUCT, THE GUIDES ARE V0100112 FOR A JOURNEY II PLAN AND THE LABEL IS V0100106 FOR A GENESIS II SURGERY. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832202 ↗
• InjuryAug 18, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE NS VIS ADPT GUIDE JII KIT DESIGN HAD A LATERAL CUTTING SLOT THAT MADE DIFFICULT TO PLACE THE TIBIAL CUTTING GUIDE INTO THE INCISION, WHICH LED TO TWO (2) CUTS OF THE DISTAL TO 4MM, TWO (2) CUTS OF THE PROXIMAL MEDIAL TIBIA TO 4MM. SURGERY WAS RESUMED, WITH THE SAME DEVICE AFTER A NON-SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338587 ↗
• InjuryFeb 12, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE WHILE USING THE NS VIS ADPT GUIDE JII KIT, THE WING OF THE TIBIA BLOCK BROKE OFF IMMEDIATELY ONCE SAWBLADE WAS STARTED (WHILE INSIDE THE PATIENT). A DELAY OF LESS THAN 30 MIN WAS REPORTED. THERE WAS A CHANGE IN TECHNIQUE DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321310 ↗
• MalfunctionSep 17, 2020Inadequacy of Device Shape and/or Size; Defective Device; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THE VISIONAIRE FEMUR BLOCK DID NOT FIT PATIENT ANATOMY. FAULT IN DEVICE WAS NOTICED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A SN BACKUP DEVICE. A SURGICAL DELAY LESS OR EQUAL TO 30 MIN WAS REPORTED. THE OUTCOME OF THE PATIENT IS STILL UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551740 ↗