JOURNEY 71422432Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 2 · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556088197), received between Mar 31, 2019 and Feb 21, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Premature Separation1
Patient problems
- Arthritis2
- Inadequate Osseointegration2
- Injury2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT DURING THE UNICOMPARTMENTAL KNEE ARTHROPLASTY, AN INSERT WOULD NOT LOCK WITH THE JRNY UNI TIBIAL BASE RM/LL SZ 2. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18754477 ↗InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2019 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AND PROGRESSION OF THE ARTHRITIS. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 WERE ALL COMPONENTS WHERE EXCHANGE. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Arthritis; Inadequate Osseointegration
MAUDE report 15358790 ↗InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AND PROGRESSIVE ARTHRITIS THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017. THE TIBIAL AND FEMORAL COMPONENT AS WELL AS THE TIBIAL BASEPLATE WERE EXCHANGE. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Arthritis; Inadequate Osseointegration
MAUDE report 15358744 ↗InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO THE PATIENT DEVELOPING PATELLA-FEMORAL PAIN. THE PATIENT HAD A UNI REPLACEMENT DONE.
Patient problems: Injury
MAUDE report 9511324 ↗InjuryMar 31, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN DUE TO LOOSENING OF TIBIAL BASE 3 MONTHS AFTER IMPLANTATION DURING PRIMARY TKR, REVISION SURGERY WAS REQUIRED AS A RESULT ¿ ANOTHER TKR WAS PERFORMED.
Patient problems: Injury
MAUDE report 8468093 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
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- 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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