VISIONAIRE V0100012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010653116), received between Apr 24, 2018 and Dec 11, 2019 — classified as 1 injury, 1 malfunction.

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

• MalfunctionDec 11, 2019Unstable; Unstable

  IT WAS REPORTED THAT REVISION SURGERY WILL BE PERFORMED DUE TO PROBABLE INSTABILITY OF THE KNEE JOINT. IN THE PRIMARY SURGERY, A GII SYSTEM WAS IMPLANTED ON THE RIGHT KNEE. DURING THE MEDICAL CONSULT, IT WAS NOTICED THE LABEL FOR THE VISIONAIRE INSTRUMENT USED WAS FOR A LEFT KNEE, WHICH MAY BE CAUSING THE INSTABILITY PROBLEM IN THE PATIENT. IT IS UNCERTAIN IF THE DEVICES WERE MISLABELED OR IF A MISTAKE WAS MADE AT THE TIME OF THE IMPLANTATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449008 ↗
• InjuryApr 24, 2018Difficult To Position; Difficult To Position

  IT WAS REPORTED THAT THE TIBIAL CUTTING BLOCK APPEARED THAT IS WAS GOING TO CUT IN VARUS.

  Patient problems: No Information

  MAUDE report 7454991 ↗