JOURNEY 74018609Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY FLEXION EXTENSION BLOCK LARGE · Class 1
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010557100), received between Feb 11, 2021 and Apr 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, IT WAS NOTICED THAT THE WHITE RETAINING RINGS OF ONE (1) JOURNEY FLEX EXT BLOCK LG FRACTURED WHEN INSERTING ONE (1) JOURNEY FLEX-EXT SPACER 9MM. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749031 ↗MalfunctionApr 26, 2021Break; Break
IT WAS REPORTED AFTER THE PROCEDURE THAT THE SPACER BLOCK DID NOT FUNCTION (DID NOT HOLD THE INSERT). NO PATIENT INVOLVED IN THE CASE. AFTER PRODUCT EVALUATION IT WAS DETERMINED THAT THE DEVICE'S RETAINING RINGS CAME OUT AND ARE MISSING, RENDERING THE DEVICE INOPERABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11729693 ↗MalfunctionFeb 11, 2021Break; Break
IT WAS REPORTED THAT THE JOURNEY FLEX EXT BLOCK LG BROKE IN HALF. UNKNOWN WHEN THIS HAPPENED OR IF THERE IS A PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11312300 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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