JOURNEY 71436144Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY UNI ALL POLY TIBIA TRIAL INSERT SIZE 5-6/7MM · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010589989), received between Apr 11, 2022 and Apr 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2022Break; Break
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNYUNI APTIB TRINSRT S5-6/7MM BROKE IN HALF DURING A PROCEDURE. SURGERY WAS RESUMED WITHOUT ANY ISSUES. IT IS UNKNOWN IF THERE WAS ANY DELAY AS CONSEQUENCE OF THIS PROBLEM. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14072282 ↗
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- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.