Skip to content

VISIONAIRE V0100030Recalls & reported problems

Smith & Nephew, Inc. · VISIONAIRE DISTAL FEMUR CUTTING BLOCK - JOURNEY BI CRUCIATE SYSYTEM · Class 2

All models of VISIONAIRE (25)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556077191), received between Oct 8, 2018 and Oct 8, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Injury1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 8, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT WHEN VIEWING THE POST OPERATIVE X-RAYS, IT APPEARED THAT THE PATIENT'S LEG WAS LEFT IN EXTREME VALGUS.

    Patient problems: Injury; No Code Available

    MAUDE report 7945079 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page