JOURNEY 74031243Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II ARTICULAR STABILIZED ARTICULAR INSERT TRIAL SIZE 5-6 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 00885556786857), received between Jun 30, 2023 and Nov 9, 2024 — 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.
MalfunctionNov 9, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TRIALING IN A TKA SURGERY, ONE (1) JII AS ART ISRT TRL SZ 5-6 LT 9MM WAS SPLIT IN HALF. 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 20646857 ↗MalfunctionJun 30, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JII AS ART ISRT TRL SZ 5-6 LT 9MM BROKE WHILE INSERTING IT. IT IS UNKNOWN HOW THE PROBLEM WAS RESOLVED AND IF IT CAUSED ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17239674 ↗
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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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