JOURNEY 74023232Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY ARTICULAR INSERT BCS STANDARD 3-4 RIGHT 10MM · 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
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010555007), received between Aug 24, 2018 and Dec 26, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
4 other recalls cover devices cleared under the same FDA submission (K042515, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Positioning Problem1
- Unstable1
Patient problems
- Failure of Implant3
- Injury1
- Joint Dislocation1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2024Fracture; Fracture
IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2012, THE INSERT (UNKN ORTHOPAEDIC RECONSTRUCTION DEV) POST BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS GOOD.
Patient problems: Failure of Implant
MAUDE report 21019192 ↗InjuryOct 8, 2024Fracture; Fracture
IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE POST OF THE JOURN ART INS BCS STD 3-4 RT10. BROKE OFF. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A JOURN ART INS BCS STD 3-4 RT10 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 20397708 ↗InjuryFeb 24, 2021Positioning Problem; Positioning Problem
IT WAS REPORTED THAT A PATIENT HAD A MANIPULATION UNDER ANESTHESIA SINCE TWO PREVIOUS DISLOCATIONS OCCURRED IN THE PAST. THE DECISION WAS MADE TO OPEN THE JOINT AND INVESTIGATE FURTHER AS NO DISLOCATION WAS POSSIBLE DURING THE MUA. UPON OPENING THE JOINT THE SURGEON DETERMINED THAT UNDER EXTREME EFFORT DISLOCATION WAS THEORETICALLY POSSIBLE. THE JOURN ART INS BCS STD 3-4 RT10 WAS REPLACED, THE OTHER IMPLANTS WERE FIRM. THE SURGEON DECIDED AFTER TRIALING, TO INSTALL A THICKER REVISION POLY.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 11371590 ↗InjurySep 25, 2020Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INSERT FAILURE, THE POST WAS BROKEN. THE PHYSICIAN NEEDED TO REPLACE THE LINER WITH A NEW REVISION JOURNEY INSERT SO A JOURNEY REVISION INSERT TRIAL WITH BIGGER POST WAS USED TO FIX THE ISSUE. THE ORIGINAL SURGERY WAS AROUND 11 YEARS AGO. THERE WAS NO DELAY IN REVISION. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Injury
MAUDE report 10590023 ↗InjuryAug 24, 2018Unstable
IT WAS REPORTED THAT A REVISION SURGERY WAS DONE ON THE PATIENT. REASON FOR REVISION - PT SLIPPED AT WORK RESULTING IN INSTABILITY. AT REVISION, INSERT EXCHANGED FOR A JOURNEY BCS REVISION INSERT. AT TIME OF REMOVAL, UNUSUAL WEAR PATTEN NOTICED AND COMMENTED ON BY SURGEON. PATIENT FIT AND HEALTHY.
Patient problems: No Code Available
MAUDE report 7814914 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042515, 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
- Z-0003-2019 · Jun 13, 2018 · Open, ClassifiedJOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
- Z-0001-2019 · Jun 13, 2018 · Open, ClassifiedJourney BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
- Z-0002-2019 · Jun 13, 2018 · Open, ClassifiedJOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112
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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