JOURNEY 71436134Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/9MM · Class 2
All models of JOURNEY (566)
Data updated Oct 16, 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 03596010588111), received between Jul 24, 2020 and Feb 27, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Crack2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A UKA SURGERY, A PIECE OF ONE (1) JOURNEY UNI TIB TR INS SZ3-4/9MM BROKE OFF FROM THE UNDERSIDE WHILE REMOVING THE TRIAL INSERT. THE PIECE OF PLASTIC WAS ACCOUNTED FOR RETRIEVED USING FORCEPS. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18792202 ↗MalfunctionNov 23, 2021Break; Crack; Break; Crack
IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861059 ↗MalfunctionSep 17, 2021Crack; Crack
IT WAS REPORTED THAT, A NAIL PROX DROP HAD A CONNECTING ISSUE AND THE OTHER REPORTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12488706 ↗MalfunctionApr 18, 2021Break; Break
IT WAS REPORTED THAT DURING INSPECTION IN WAREHOUSE THE DEVICES WERE FOUND DEFECTIVES. THE TIBIAL SPACER BLOCK STANDARD WAS NOTICED WITH AN UNSPECIFIC FAILURE MODE (CASE: (B)(4)). THE JOURNEY FEMORAL IMPLANT IMPACTOR BUMPER RIGHT (CASE: (B)(4)) WAS NOTICED BROKEN. THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT (CASE: (B)(4)), UNIVERSAL INSERT SPACER SIZE 1-2 18 MM (CASE: (B)(4)), JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 8 MM (CASE: (B)(4)), UNIVERSAL INSERT SPACER SIZE 1-2 13 MM (CASE: (B)(4)) AND JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 9 MM (CASE: (B)(4)) WERE NOTICED CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11683498 ↗MalfunctionMar 30, 2021Break; Break
IT WAS REPORTED THAT DURING AN INSPECTION IN THE WAREHOUSE IT WAS NOTICED THAT THE JOURNEY UNI TIBIAL TRAIL INSERT SIZE 3-4/ 9 MM WAS CRACKED. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11593500 ↗MalfunctionJul 24, 2020Break; Break
IT WAS REPORTED THAT THE JOURNEY UNI TIB TR INS SZ3-4/9MM WAS FOUND TO BE CRACKED. NO CASE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10319535 ↗
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- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- 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 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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