Harmony 74016268Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY LOCKING TIBIAL IMPACTOR · Class 1
- 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 00885556746868), received between Jun 22, 2025 and Apr 20, 2026 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionApr 20, 2026Fracture
IT WAS REPORTED THAT DURING A TKA SURGERY, THE JOURNEY LOCKING TIBIAL IMPACTOR BROKE IN HALF. IT DID NOT FALL INTO THE WOUND. PIECES RETRIEVED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924274 ↗MalfunctionJun 22, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, THE ORANGE PIECE AT THE VERY TOP OF ONE (1) JOURNEY LOCKING TIBIAL IMPACTOR BROKE IN HALF. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO INJURY NOR ANY DELAY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304603 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.