JOURNEY 74031257Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II MEDIAL DISHED ARTICULAR INSERT TRIAL SIZE 3-4 LEFT 9MM · Class 1
All models of JOURNEY (566)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556785201), received between Mar 4, 2025 and Aug 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, WHILE INSERTING THE JII MD ART ISRT TRL SZ 3-4 LT 9MM SNAPPED IN HALF. AT THIS TIME, IT IS UNKNOWN IF ANY PIECES FELL INSIDE THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901429 ↗MalfunctionMar 4, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE JII MD ART ISRT TRL SZ 3-4 LT 9MM BROKE WHILE IT WAS BEING REMOVED. ALL PIECES WERE RECOVERED AND NONE FELL INTO THE PATIENT. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21519025 ↗
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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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