VISIONAIRE V0100107Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556656372), received between Jul 26, 2019 and Apr 2, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Compatibility 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A TKA SURGERY USING VISIONAIRE FEMORAL CUTTING BLOCK, MORE BONE WAS RESECTED FROM THE FEMORAL POSTERIOR MEDIAL CONDYLE THAN PLANNED. THE PLANNED CUT WAS 9.5MM, BUT THE MEASURED RESECTION WITH A CALIPER WAS 12.5MM. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 19029206 ↗
• MalfunctionJul 29, 2020Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING TKA SURGERY, THE FEMUR CUTTING GUIDE VIS ADPT GUIDE LGNP FEM WAS NOT MAKING CONTACT WITH ANTERIOR HOOK AND WAS DIFFICULT TO PIN DOWN DUE TO ROCKING. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10337967 ↗
• InjuryJul 17, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING TKA SURGERY, THE FEMUR CUTTING GUIDE VIS ADPT GUIDE LGNP FEM DID NOT MAKE CONTACT WITH THE FEMUR ANTERIOR HOOK OR WITH DISTAL. THE SURGEON HAD TO CHANGE SURGICAL TECHNIQUE AND SWITCHED TO STANDARD INSTRUMENTS. THE PROCEDURE FINISHED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10292542 ↗
• MalfunctionJul 26, 2019Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO PLACE THE FEMORAL CUTTING BLOCK ON THE PATIENT, HE WAS HAVING BLOCK FIT ISSUES. THE BLOCK DID NOT APPEAR TO MATCH THE ANTERIOR CORTEX OF THE PATIENT'S FEMORAL BONE ANATOMY. THE SURGEON DID NOT USE THE CUTTING GUIDE AND WENT WITH STANDARD INSTRUMENTS. NO DELAYS REPORTED. NO PATIENT INJURIES REPORTED. IT IS UNKNOWN IF AN S&N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8834206 ↗