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JOURNEY 74031214Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II TKA FEMORAL TRIAL RIGHT SIZE 4 · Class 2

All models of JOURNEY (566)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010671998), received between Oct 8, 2020 and Mar 26, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 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: 1 reportsApr 2025: 0 reportsMay 2025: 0 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

  • Fracture3
  • Connection Problem1
  • Incomplete or Inadequate Connection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 26, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II TKA FEM TRIAL RT SZ 4 WAS IMPACTED ONTO FEMUR AND THE TRIAL SPLIT. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21696437 ↗
  • InjurySep 6, 2022Fracture; Fracture

    IT WAS REPORTED THAT DURING TKA SURGERY THE JRNY II TKA FEM TRIAL RT SZ 4 BREAK WITHIN THE PATIENT'S WOUND, ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15363114 ↗
  • MalfunctionAug 31, 2022Fracture; Fracture

    IT WAS REPORTED THAT DURING A TKA A JRNY II TKA FEM TRIAL RT SZ 4 WAS FOUND BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH AN S+N BACKUP DEVICE INSTEAD. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15331631 ↗
  • MalfunctionJun 17, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

    IT WAS REPORTED THAT, DURING A TKA, A JRNY II TKA FEM TRIAL RT SZ 4 CASE(B)(4) AND A JOURNEY II TKA FEMORAL TRIAL SZ 3 RIGHT CASE (B)(4) DO NOT FIT IN TO THE 3-5 BOX COLLET. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY USING A BACK-UP DEVICE. PATIENT WAS NOT IMPACTED BY THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12020691 ↗
  • MalfunctionOct 8, 2020Connection Problem; Connection Problem

    IT WAS REPORTED THAT DURING SURGERY, TRIAL WOULD NOT ALLOW THE BOX TRIAL TO LOCK/ENGAGE. PROCEDURE CONCLUDED WITH THE SAME DEVICE WITHOUT A DELAY OR INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10648079 ↗

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Sources and updates

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