JOURNEY II UNI 74026026Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II UNI OXINIUM FEMORAL COMPONENT 6 LM/RL · Class 2 · Implant
All models of JOURNEY II UNI (8)
Data updated Oct 18, 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 00885556675793), received between Oct 12, 2024 and Oct 9, 2025 — classified as 2 injuries.
3 other recalls cover devices cleared under the same FDA submission (K190085); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A TKA, PATIENT CONTRACTED A VERY AGGRESSIVE VIRUS THAT INFECTED HER LEG. PATIENT COULD NOT SLEEP DUE TO THE PAIN AND THE INFECTION OF THE PROTHESIS. THIS CAUSED PERMANENT DAMAGE SUCH AS THE PATELLA OUT OF AXIS. IN ADDITION, THE BLOOD VALUES WERE 16 TIMES ABOVE THE TOLERANCE. IT IS UNKNOWN HOW THIS ADVERSE EVENT HAS BEEN ADDRESSED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23263118 ↗InjuryOct 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A LEFT UKA PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2020 DUE TO LEFT MEDIAL KNEE PRIMARY OSTEOARTHRITIS, THE PATIENT EXPERIENCED MECHANICAL SYMPTOMS OF THE LEFT KNEE PROSTHESIS WITH CATCHING AND LOCKING SENSATION AND THE PRESENCE OF A LOOSE BODY (UNKNOWN TISSUE). THE PATIENT UNDERWENT ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2022 WITH REMOVAL OF THE LOOSE BODY. THE PROCEDURE WENT UNEVENTFULLY AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.
Patient problems: Loss of Range of Motion
MAUDE report 20435203 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190085. One submission often covers many models, so check the product and lot details in each record.
- Z-1393-2023 · Mar 27, 2023 · Open, ClassifiedJOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
- Z-2132-2020 · Jan 28, 2020 · TerminatedJOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti
- Z-2133-2020 · Jan 28, 2020 · TerminatedJOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti
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
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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