JOURNEY 71422241Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY UNI TIBIA INSERT SIZE 1-2 LEFT MEDIAL/RIGHT LATERAL 8MM · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010582041), received between Oct 30, 2023 and Nov 21, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K061011, K230653); they may or may not involve this specific model.
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
- Device Dislodged or Dislocated2
Patient problems
- Joint Dislocation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER A JOURNEY UNI SYSTEM HAD BEEN IMPLANTED ON (B)(6) 2023, THE PATIENT EXPERIENCED AN INLAY DISLOCATION AFTER TWISTING TRAUMA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THE INCIDENT. THE FOLLOWING INTRA-OP FINDINGS WERE NOTED: (I) ONCE THE CAPSULE WAS OPENED, IT IS ALREADY EVIDENT THAT THE INLAY WAS COMPLETELY DISLOCATED FORWARD, SO IT WAS REMOVED; (II) THE NOTCHED WAS DAMAGED BECAUSE OF INCREASED WEAR AND TEAR WITH THE OXONIUM FEMORAL PROSTHESIS IN PLACE; AS A RESULT, THE DECISION IS NOW MADE TO CHANGE THE FEMORAL COMPONENT. THE PATIENT WAS DISCHARGED ON 15-AUG-2023 WITH WOUND TREATMENT, PROPHYLACTIC MEDICATION, INDICATIONS FOR PHYSICAL EXERCISE, AND FOLLOW-UP X-RAY EXAMINATIONS.
Patient problems: Joint Dislocation
MAUDE report 18187133 ↗InjuryOct 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT, AFTER AN UKA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE JOURNEY UNI TIBINRT S1-2LM/RL8MM DISLOCATED FORWARD DURING A LUNGE. IT IS UNKNOWN HOW THIS INCIDENT HAS BEEN ADDRESSED THUS FAR AND SO IS THE PATIENT'S CURRENT HEALTH STATUS.
Patient problems: Joint Dislocation
MAUDE report 18029125 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061011, K230653. One submission often covers many models, so check the product and lot details in each record.
- Z-2621-2023 · Aug 31, 2023 · Open, Classifiedsmith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- 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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