JOURNEY 71422268Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY UNI TIBIA INSERT SIZE 5-6RIGHT MEDIAL/LEFT LATERAL 11MM · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010582270), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2020Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY ON (B)(6) /2019, WAS REHABILITATING WELL WITH MINIMAL PAIN. HOWEVER, WHEN WALKING DOWN A SLOPE, THE PATIENT SLIPPED AND FELL, HAVING AN IMMEDIATE ONSET OF KNEE PAIN AND CATCHING. THE X-RAYS REVEALED POLY HAD FLIPPED OUT OF THE TIBIAL TRAY. REVISION SURGERY WAS PERFORMED AND DURING THE PROCEDURE, FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. POLY WAS LOOSE AND NOT SITTING IN THE TIBIAL TRAY AS EXPECTED AND EXPLANTED. THE SURGEON ALSO ELECTED TO EXPLANT THE TIBIAL TRAY, RECUT THE TIBIAL WITH MORE SLOPE TO IMPROVE FLEXION SPACE AND LOADING. HE RE-IMPLANTED THE SAME SIZE TIBIAL TRAY AND INSERTED A SIZE 11 POLY.
Patient problems: Injury
MAUDE report 9728096 ↗
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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