VISIONAIRE V0100082Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556492680), received between Nov 21, 2017 and Apr 19, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE VIS CUT GUIDE JII KIT LT PINHOLES INCORPORATED WERE INCORRECT. SURGEON WAS UNABLE TO USE THE GUIDES DUE TO JAPAN REGULATIONS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141722 ↗
• MalfunctionJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, BLOCK HAD NOT ENOUGH RESECTION ON THE PROXIMAL MEDIAL SIDE, WAY TOO TIGHT MEDIALLY, ANGLE AND SLOPE WERE OFF. FURTHER INFORMATION REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9567238 ↗
• InjuryMay 14, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT VISIONAIRE CUTTING BLOCK ON FEMORAL SIDE DID NOT FIT APPROPRIATELY ( THE ANTERIOR PORTION OF BLOCK CURVED UP AND DID NOT MATCH ANATOMY OF BONE) AS SUCH SURGEON AND CLINICAL NURSE HELD AND PINNED THE BLOCK MANUALLY WHERE THEY FELT WAS APPROPRIATE. THE ANTERIOR CORTEX WAS NOTCHED, THAT AREA WAS GRAFTED BY PATIENT¿S HOST BONE WHEN COMPONENTS WERE IMPLANTED. MINOR DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 8610487 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT THE FEMORAL GUIDE BROKE DURING DISTAL FEMORAL RESECTION. BACKUP METAL CUTTING BLOCK WAS AVAILABLE. NO ADDITIONAL TIME WAS ADDED TO PROCEDURE AND PATIENT CARE/SAFETY WAS NOT AFFECTED. THE BROKEN PART IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245835 ↗
• InjuryNov 21, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE SURGEON PLACED THE FEMUR BLOCK ON AND NOTED THAT IT WAS ROCKING AND DID NOT FIT AS WELL AS OTHER FEMUR BLOCKS. SURGEON PINNED AND CUT THROUGH THE BLOCK. THE ANTERIOR RESECTION SEVERELY NOTCHED, AND THE SURGEON BAILED TO A LEGION REVISION WITH A STEM.

  Patient problems: Injury

  MAUDE report 7050242 ↗