VISIONAIRE V0100022Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010653130), received between Jul 9, 2018 and May 13, 2021 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (4 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.

• InjuryMay 13, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING TKA, THE VIS CUT GUIDE LGNP KIT LT DID NOT FIT AS EXPECTED. THE PROCEDURE TECHNIQUE HAD TO BE CHANGED TO CONVECTIONAL MANUAL METHOD, POSITIONING THE FEMUR BLOCK FOR ABOUT 20MM POSTERIOR FEMORAL CUT AND UPSIZED TO AN 8. IT IS UNKNOWN IF THERE WAS ANY SIGNIFICANT SURGICAL DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11822367 ↗
• InjuryFeb 22, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING TKA SURGERY THE SURGEON USED THE FEMUR CUTTING BLOCK ON THE FEMUR NOTICED THAT DISTAL CUT WAS OFF. HAD TO TAKE AN ADDITIONAL +3 TO +4MM DISTAL MEDIALLY IN ORDER TO CORRECT VARUS/VALGUS. FEMUR WAS CUT IN TOO MUCH VALGUS. THERE WAS A DELAY OF 15 MINS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357007 ↗
• InjuryApr 9, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING SURGERY THE VISIONAIRE TIBIAL CUTTING BLOCK DID NOT MAKE CORRECT CUTS. SURGEON HAD TO USE S&N MANUAL INSTRUMENTATION AS THE BACKUP TO COMPLETE THE SURGERY, DIVERTING FROM THE ORIGINAL TECHNIQUE, AND MADE EXTRA PROXIMAL TIBIAL RESECTION TO BALANCE THE KNEE. THE FINAL OUTCOME OF THE PATIENT SO FAR SO GOOD. SURGEON WAS VERY UNHAPPY WITH THE BLOCKS, THE PROCEDURE WAS DELAYED FOR LESS THAN 30 MINUTES.

  Patient problems: Injury; No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 8495400 ↗
• MalfunctionFeb 19, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT FEMUR CUTTING SLOT WAS NOT FULLY FORMED ON BLOCK. SURGEON WENT TO CUT THROUGH BLOCK, AND THE SAW BLADE COULD NOT FIT THROUGH. NO DELAY, BACK-UP DEVICE WAS NOT AVAILABLE AND NO PATIENT INJURY OR IMPACT WAS INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351567 ↗
• MalfunctionJan 31, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE TIBIA BLOCK WOULD NOT FIT. MECHANICAL INSTRUMENTS HAD TO BE USED. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292440 ↗
• MalfunctionJan 31, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE TIBIA BLOCK WOULD NOT FIT. MECHANICAL INSTRUMENTS HAD TO BE USED. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292382 ↗
• 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 8189589 ↗
• MalfunctionDec 13, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY, THE DISTAL HOLES FOR SPIKES ON DCF 4IN1 CUTTING BLOCK PREPARED THROUGH VISIONAIRE MOLD. WHEN ATTEMPTING TO PLACE DCF 4IN1 CUTTING BLOCK ON PREPARED SURFACE THE SPIKES DID NOT LINE UP WITH THE PREPARED HOLES. WAS OFF BY APPROXIMATELY 1-2MM. WHEN COMPARING THE MOLD TO THE SPIKES ON THE BLOCKS ON THE DISTAL SURFACE OF THE MOLD THEY WERE ALIGNED, HOWEVER IT WAS NOT ALIGNED ON THE PROXIMAL SURFACE OF THE MOLD. THIS WAS COMPARED IN MULTIPLE SIZES TO RULE OUT BLOCK SPIKE BENDING. SURGEON HAD TO REVERTED TO A MANUAL TKR, SIMPLY COMPLETED PROCEDURE WITHOUT THE USE OF VISIONAIRE BLOCK. THERE WAS A DELAY SHORTER THAN 30 MINUTES. FINAL OUTCOME OF THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161918 ↗
• MalfunctionNov 5, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A MALFUNCTION OCCURRED DURING SURGERY. THE CUTTING SLOT OF THE FEMUR BLOCK WAS NOT COMPLETELY MOLDED SO THE SURGEON ENDED UP PHYSICALLY CUTTING THROUGH THE FEMUR BLOCK. STANDARD DISTAL FEMORAL CUTTING BLOCK USED. NO IMPACT TO THE PATIENT OCCURRED. THE PATIENT STILL EXPERIENCED A SUCCESSFUL TOTAL KNEE REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8040447 ↗
• MalfunctionAug 14, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SIZING AND FEMORAL ROTATION DISCREPANCY WAS IDENTIFIED DURING A TOTAL KNEE USING A VISIONAIRE CUTTING BLOCK. THE VISIONAIRE PLAN WAS DETERMINED TO BE A 7 FEMUR AND 5 TIBIA. ONCE THE DISTAL FEMUR WAS RESECTED AND SZ 7 4 IN 1 FEMORAL BLOCK WAS VISUALIZED ON BONE IT WAS APPARENT THE SIZING WAS OFF. AT THIS POINT DR. SNYDER OBSERVED THE FEMORAL ROTATION TO BE TOO EXTERNAL AS WELL. TO CORRECT THIS WE USED STANDARD INSTRUMENTATION TO SIZE THE FEMUR TO SIZE 6, AND ALSO ADJUSTED THE ROTATION APPROX. 3-4 DEGREES INTERNAL. THE PATIENT WAS NOT HARMED OR SURGERY DELAYED SINCE ALL INSTRUMENTATION AND IMPLANTS WERE AVAILABLE. HOSPITAL THREW BLOCKS IN TRASH, SO NOTHING IS AVAILABLE TO RETURN FOR REVIEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781014 ↗
• InjuryJul 24, 2018Material Integrity Problem; Material Integrity Problem

  BAD CUTTING SLOT. SLOT SEEMED TO BE HALF FILLED IN, KICKED THE SAW BLADE WHEN TRYING TO CUT. HAD TO RECUT WITH METAL BLOCK BECAUSE CUT WAS UNEVEN, ENDED UP USING STEMMED TIBIA COMPONENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716747 ↗
• InjuryJul 9, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE BLOCK BAILED ON FEMUR 5-10 DEGREES TOO MUCH INTERNAL ROTATION, USED SIZER AND DROPPED TO A 6. DROPPED FROM 8 TO 6 ON TIBIA TOO. PLAN WAS CHANGED AND ALIGNMENT WAS CHANGED PRIOR TO MAKING BONE CUTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7672002 ↗