Skip to content

JOURNEY 74031226Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II TOTAL KNEE FEMORAL TRIAL LT SZ 6 · Class 2

All models of JOURNEY (566)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010672032), received between Jun 18, 2018 and May 30, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1
  • Material Fragmentation1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT, DURING TKA, WHILE REMOVING ONE (1) JRNY II TKA FEM TRIAL LT SZ 6, THE BALL BEARING/SPRING SHOT OUT OF FEMORAL TRIAL. PIECE WAS FOUND EXTERNAL TO PATIENT AND PLACED ON THE BACK TABLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22117009 ↗
  • MalfunctionNov 14, 2022Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

    IT WAS REPORTED THAT, DURING TKA PROCEDURE, THE JRNY II TKA FEM TRIAL LT SZ 6 WAS REPORTED AS DAMAGED. ACCORDING TO THE PHOTO ATTACHED, THE DEVICE IS CUT AND TORN. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15787147 ↗
  • InjuryJun 18, 2018Break; Break

    IT WAS REPORTED THAT A PIECE OF METAL FELL OFF THE BACK OF THE FEMORAL TRIAL INTO THE PATIENT. IT WAS REMOVED FROM PATIENT AND NO IMPACT TO THE SURGERY AS IT¿S WAS A LARGE FRAGMENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7609281 ↗

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