JOURNEY 74031224Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II TKA FEMORAL TRIAL LEFT SIZE 4 · 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 03596010671905), received between Nov 12, 2019 and Jan 18, 2023 — 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 18, 2026.
Most reported problems
Device problems
- Break4
- Crack1
- Fracture1
- Mechanical Jam1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- No Information1
- No Known Impact Or Consequence 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 18, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE SURGEON ATTEMPTED TO IMPACT THE JRNY II TKA FEM TRIAL LT SZ 4, A PIECE CHIPPED OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16195148 ↗MalfunctionApr 9, 2022Crack; Mechanical Jam; Naturally Worn; Scratched Material; Crack; Mechanical Jam; Naturally Worn; Scratched Material
IT WAS REPORTED THAT, THE JRNY II TKA FEM TRIAL LT SZ 4 WOULD GET CAUGHT UP IN THE LATERAL SIDE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED. THE INVESTIGATION FOUND THE DEVICE HAS CRACKS IN THE METAL, SEVERAL GOUGES AND IS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14068442 ↗MalfunctionAug 19, 2020Break; Break
IT WAS REPORTED THAT THE JOURNEY II TKA FEM TRIAL LEFT SIZE 4 IS BROKEN AND NEEDS TO BE REPLACED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Information
MAUDE report 10427089 ↗MalfunctionJun 15, 2020Break; Break
IT WAS REPORTED THAT UPON INSPECTING THE INSTRUMENTS IT WAS NOTICED THAT THE LATERAL SIDE CAPTURE WAS BROKEN AND CRACKED. NO CASE INVOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10156246 ↗MalfunctionDec 17, 2019Break; Break
IT WAS REPORTED THAT DURING A PRIMARY SURGERY, THE FEMUR TRIAL SPLIT IN TWO DURING INSERTION. A BACKUP DEVICE WAS AVAILABLE BUT THE SURGERY WAS DELAYED FOR NO MORE THAN 30 MIN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9480086 ↗MalfunctionNov 12, 2019Break; Break
IT WAS REPORTED THAT DURING THE PROCEDURE A SMALL SLIVER OF METAL WAS SEEN FALLING OFF THE TRIAL UPON IMPACTION OF THE TRIAL. NO INJURIES OR DELAYS REPORTED. BACKUP DEVICE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9309559 ↗
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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