VISIONAIRE V0200022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556583067), received between Jul 11, 2017 and Dec 2, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2019Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING SURGERY AFTER THE DISTAL FEMORAL CUT WAS MADE, THE PIN HOLES DIDN¿T ALIGN CORRECTLY. IT WAS FOUND THEN THE LABELS AND DASHBOARD WERE LISTED AS JOURNEY II INSTEAD OF A LEGION. VISIONAIRE BLOCKS WERE ORIGINALLY FOR A JOURNEY II BUT SINCE THE PATIENT HAD A LARGE DEFORMITY IT WAS CHANGED TO A LEGION LEFT. S+N BACK-UP AVAILABLE AND USED. DELAY UNDER 30 MIN.

  Patient problems: Injury

  MAUDE report 9395601 ↗
• MalfunctionApr 2, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE BLOCK HAD A VERY POOR FIT. NO DELAY. NO REVISION SURGERY PERFORMED. PROCEDURE WAS COMPLETED WITH STANDARD INSTRUMENTATION. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8476054 ↗
• InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON CONSIDERS THE TIBIAL ALLIGNMENT OF THE KNEE NOT TO BE SATISFACTORY FOLLOWING THE CUT MADE WITH THE CUTTING GUIDE, SEEING ALIGNMENT IN VALGUS CLOSE TO 10º.

  Patient problems: Injury; No Code Available

  MAUDE report 6701364 ↗