VISIONAIRE V0200023Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556583074), received between Jul 13, 2017 and Nov 3, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE FEMUR BLOCK FIT PERFECTLY, SURGEON PINNED AND CUT, AFTER CUTTING THE POSTERIOR RESECTION OF THE FEMUR THE SURGEON NOTICED THAT THE POSTERIOR CUTS WERE OFF, THEY MEASURED THE RESECTION AND THEY TURNED OUT TO BE 16 MM MEDIAL AND 5 MM LATERAL. DOCTOR HELD THE FEMUR GUIDE UP TO THE FEMUR BONE AND SAID THAT THE PIN HOLES HE USED MATCHED UP TO THE GUIDE. THERE WAS A DELAY OF 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10780126 ↗
• InjuryJan 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHILE PLACING FEMUR BLOCK ON, DISTAL RESECTION WAS VERY OFF. IT SEEMED LIKE IT MADE THE ANTERIOR CUT IN 20 DEGREES OF FLEXION. SWITCHED TO STANDARD INSTRUMENTATION TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: Injury

  MAUDE report 9598308 ↗
• InjuryJun 19, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, USING A VISIONAIRE BLOCK WHICH FITTED PERFECTLY ON THE FEMUR, A CUT THAT WAS 2 MM MORE THAN THE PLANNED WAS MADE. IT IS UNKNOWN HOW WAS THE PROCEDURE CONCLUDED.

  Patient problems: Injury

  MAUDE report 8713154 ↗
• MalfunctionApr 9, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE DR SECURED THE FEMORAL CUTTING GUIDE, AS USUAL, INSERTED THE OSCILLATING SAW AND PROCEEDED WITH THE DISTAL CUT OF THE FEMUR. AS HE WAS CUTTING THROUGH, HE NOTICED PLASTIC SHAVINGS IN THE CUT. HE SAID THAT HE HAD FELT THAT THERE WAS AN OBSTRUCTION IN THE GUIDE AS IF THE SLOT WASN'T COMPLETELY OPEN. NO INJURY WAS REPORTED. PROCEDURE COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497502 ↗
• InjuryJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected; Positioning Problem

  IT WAS REPORTED THAT THE CUTTING BLOCK PRODUCED, WAS APPARENTLY WELL POSITIONED IN THE BONE WHEN USED. AFTER THAT, THE SURGEON PERFORMED A SEVERE ANTERIOR NOTCHING IN THE FEMUR, CONSIDERING THE FINAL POSITION DICTATED BY THE CUTTING BLOCK.

  Patient problems: Injury

  MAUDE report 6709770 ↗