JOURNEY 74033671Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II CR INSERT TRIAL RIGHT SIZE 7-8 9MM · Class 2
All models of JOURNEY (566)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556421819), received between Apr 16, 2019 and Jan 28, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Break1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN TRIALING AND IMPACTING ONE (1) JRNY II CR ISRT TRL RT SZ 7-8 9M, IT SNAPPED. ALL PIECES WERE ACCOUNTED FOR, AND NO PIECES FELL INTO THE PATIENT. 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 21258026 ↗MalfunctionMay 16, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A TKA, THE JRNY II CR ISRT TRL RT SZ 7-8 9M SNAPPED IN HALF DUE TO HEAVY USE. NO PIECES FELL INTO THE PATIENT. THERE WAS NO 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 19333522 ↗MalfunctionMay 8, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II CR ISRT TRL RT SZ 7-8 9M SNAPPED IN HALF WHILE TRIALING DUE TO HEAVY USE. NO PIECES IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19271011 ↗MalfunctionJul 2, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING TKA, DURING TRIALING POLYS, THE PLASTIC OF THE BOTTOM WHERE THE TRACKS ARE ENGAGED INTO THE JRNY II CR ISRT TRL RT SZ 7-8 9M CHIPPED. SURGEON WAS UNABLE TO GET THIS POLY SEATED AFTER TRYING NUMEROUS TIMES. AFTER OPENING UP ANOTHER TRAY WITH SAME SIZE POLY, SURGEON COULD SEAT THE POLY IN THE FIRST TRY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14897527 ↗MalfunctionApr 18, 2021Crack; Crack
IT WAS REPORTED THAT THE DEVICE CHIPPED AND CRACKED WHILE BEING PROCESSED. NO CASE OR PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11683527 ↗MalfunctionApr 16, 2019Break; Break
IT WAS REPORTED THAT DURING SURGERY, TRIAL SNAPPED WHILE TRYING TO INSERT IT. NO DELAY. BACKUP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8519749 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
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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