VISIONAIRE V0100106Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556656365), received between Mar 13, 2020 and Jun 7, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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.

• MalfunctionJun 7, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A VISIONAIRE ADAPTATIVE GUIDE GII (FEMORAL) DID NOT ALIGN TO THE DISTAL AND ANTERIOR FEMUR. THIS LEAD TO A CHANGE IN SURGICAL TECHNIQUE, AFTER A NON-SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084159 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, USING A VISIONAIRE ADAPTIVE GUIDE KIT GENESIS II, THE FEMORAL BLOCK WAS DIRECTED AND DID NOT FORCE OVER THE DISTAL LATERAL CONDYLE. THE DISTAL FEMUR WAS CUT, THE RESECTIONS WERE MEASURED AND HAD TO CUT AN EXTRA 4MM. IT IS UNKNOWN IF THERE WAS ANY DELAY AS A CONSEQUENCE OF THIS PROBLEM. CURRENT HEALTH STATUS OF PAIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15577956 ↗
• MalfunctionNov 10, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON WAS DISSATISFIED WITH THE FIT OF THE VIS ADPT GUIDE GII KIT BECAUSE WAS NOT SITTING FLUSH ON THE LATERAL SIDE, HOWEVER, IT WAS COMPLETELY FLUSH WITH THE MEDIAL SIDE. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787610 ↗
• MalfunctionMar 20, 2020Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE SAW BLADE DID NOT FIT THROUGH DISTAL FEMUR CUTTING SLOT. DOUBLE DOWNSIZED FEMUR FROM SIZE 7 TO SIZE 5. NOT NEARLY ENOUGH EXTERNAL ROTATION OF COMPONENT INCORPORATED INTO TIBIA CUTTING GUIDE. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED.

  Patient problems: No Information

  MAUDE report 9859879 ↗
• MalfunctionMar 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BEFORE THE PROCEDURE, IT WAS DISCOVERED THAT THE LABELING ON THE AG VISIONAIRE CUTTING BLOCK PACKAGING WAS INCORRECT. SURGEON DECIDED TO USE THE DEVICE ANYWAY. SURGICAL DELAY INFORMATION WAS NOT PROVIDED INITIALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831064 ↗