VISIONAIRE V0100023Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010653147), received between Sep 21, 2017 and Apr 26, 2021 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT IN A TOTAL KNEE ARTHROPLASTY PROCEDURE AFTER CUTTING, THE SURGEON WAS NOT ABLE TO FIT THE SPACER SO AN ADDITIONAL +2MM DISTAL RESECTION WAS TAKEN. IT WAS STILL TIGHT, SO THE SURGEON RESECTED +2MM PROXIMALLY AS WELL. THE TIBIA COMPONENT APPEARS TO BE VARUS WHILE THE FEMUR COMPONENT APPEARS VALGUS. IT IS UNKNOWN IF THERE WAS A DELAY OR THE STATE OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Physical Asymmetry

  MAUDE report 11722549 ↗
• InjuryMar 14, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ADDITIONAL BONE CUT WAS PERFORMED AFTER USING THE VISIONAIRE BLOCKS, JOURNEY I CUTTING BLOCK COULD NOT BE PLACED TO FEMUR AND TIBIA. IT SEEMED THAT PIN HOLES POSITIONS OF THE VISIONAIRE BLOCKS WERE LEGION CUTTING BLOCK TYPE, BECAUSE LEGION CUTTING BLOCK COULD BE PLACED TO FEMUR AND TIBIA. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478937 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE SURGEON FELT SOMETHING WAS OFF ABOUT IT, INSTEAD OF CUTTING THROUGH THE BLOCK HE DECIDED NOT TO USE THE DEVICE AND USE THE STANDARD INSTRUMENTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10738198 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TKA SURGEON MEASURED ON THE X-RAY AND THERE WAS ABOUT 10° MORE POSTERIOR SLOPE, ALSO THE KNEE WAS UNSTABLE IN EXTENSION WITH GAPPING IN VALGUS AND THE PATIENT HAD A VARUS KNEE. ATTACHED ARE IMAGES FROM THE PRE-OP AND POST OP.

  Patient problems: Injury; Joint Laxity; Physical Asymmetry

  MAUDE report 10394354 ↗
• InjuryApr 6, 2020Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT DURING A RIGHT TKR LEGION VISIONAIRE CASE THE TIBIAL BLOCK WAS PINNED IN PLACE AND THE CUT WAS MADE THROUGH THE BLOCK. THE GAP CHECK WAS MEASURED AND INDICATED THAT THE SPACE WAS TIGHT THAT THE SURGEON DECIDED TO TAKE THE ADDITIONAL BONE OFF THE TIBIA. IN DOING SO, THE STANDARD METAL MIS RIGHT-SIDED BLOCK WAS PLACED OVER THE TWO PINS THAT REMAINED IN THE TIBIA FROM THE VISIONAIRE BLOCK. THE TIBIAL SLOPE FROM THE CUT THROUGH THE VISIONAIRE BLOCK TO THE 3-DEGREE RIGHT-SIDED BLOCK WAS NOTICEABLY DIFFERENT IN REGARDS TO SLOPE OF THE CUT VS THE CUTTING BLOCK AND THE RESECTION CHECK THROUGH THE BLOCK. THE TIBIA WAS RE-CUT THROUGH THE STANDARD 3 DEGREE CUTTING BLOCK. OVERALL ALIGNMENT OF PROSTHESIS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927409 ↗
• InjuryNov 18, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE FEMUR NEEDED TO BE DOWNSIZED. IT IS UNKNOWN IF THERE WERE ANY DELAYS, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN S&N BACKUP DEVICE. NO PATIENT INJURIES REPORTED.

  Patient problems: Injury

  MAUDE report 9337988 ↗
• MalfunctionMar 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE VISIONAIRE BLOCKS DID NOT RESECT CORRECT CUTS ACCORDING TO THE PLAN. THE FEMORAL DISTAL MEDIAL RESECTION WAS APPROXIMATELY 1.5, THE LATERAL DISTAL RESECTION WAS APPROXIMATELY 7MM. THE PROXIMAL TIBIAL RESECTION ACCORDING TO DR (B)(6) NEEDED AND WAS CUT AN ADDITIONAL 2MM. THE BLOCKS FIT WELL TO THE BONE AND APPEARED TO BE CORRECTLY ALIGNED. THE POLY SELECTED AFTER ALL ADDITIONAL RESECTIONS WAS A 9MM THICKNESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409294 ↗
• MalfunctionFeb 24, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON ATTEMPTED TO CUT THROUGH THE FEMUR BLOCK SLOT, HE NOTICED THE CUTTING SLOT WASN'T COMPLETELY EXTRUDED, THERE WAS A THIN LAYER OF NYLON CLOSING OFF ONE SIDE OF IT. WHEN HE WENT TO CUT THROUGH THE TIBIA BLOCK, THE MIS WING OF THE CUTTING SLOT SNAPPED OFF AND FLEW ACROSS THE ROOM. THE SURGEON WAS ABLE TO USE OUR BLOCKS AS A PIN GUIDE, BUT HAD TO CUT THROUGH THE STANDARD METAL CUTTING BLOCKS TO MAKE HIS DISTAL AND PROXIMAL CUTS. NO DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364841 ↗
• MalfunctionDec 21, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY THE BLOCKS DID NOT FIT. THE SURGEON DIDN´T USE THE BLOCKS AND CHANGED THE TECHNIC IN ORDER TO COMPLETE THE SURGERY. NO DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189768 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TIBIA FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7945158 ↗
• InjuryMay 5, 2018Fitting Problem; Fitting Problem

  BLOCK DID NOT FIT PATIENT ANATOMY. BLOCK WAS THROWN AWAY BY ACCOUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489380 ↗
• InjurySep 21, 2017Defective Component; Defective Component

  IT WAS REPORTED THAT MORE BONE WAS CUT THAN EXPECTED IN THE PATIENT'S ANTERIOR FEMUR DUE TO A NOTCH ON THE CUTTING BLOCK. NO PATIENT SYMPTOMS HAVE BEEN REPORTED DUE TO THE ISSUE AND NO SURGICAL OR MEDICAL INTERVENTION HAS BEEN PERFORMED OR DETERMINED TO BE NECESSARY.

  Patient problems: Injury

  MAUDE report 6882763 ↗