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
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 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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