JOURNEY 74023233Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY ARTICULAR INSERT BCS STANDARD 3-4 RIGHT 11MM · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010555014), received between Dec 27, 2017 and Jun 24, 2024 — classified as 6 injuries.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant4
- Joint Dislocation1
- Joint Laxity1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2024Fracture; Fracture
IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2012, PATIENT'S INSERT BROKE. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JOURN ART INS BCS STD 3-4 RT11 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 19595733 ↗InjuryMar 30, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH IT WAS NOTICED THAT THE JOURN ART INS BCS STD 3-4 RT11 HAD A BROKEN POST. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.
Patient problems: Failure of Implant
MAUDE report 16649872 ↗InjuryDec 1, 2022Fracture; Fracture
IT WAS REPORTED THAT, AFTER A JOURNEY BCS SURGERY WAS PERFORMED ON (B)(6) 2013, THE POST OF THE JOURN ART INS BCS STD 3-4 RT11 BROKE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 15895659 ↗InjurySep 15, 2022Fracture; Fracture
IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2013, THE INSERT POST BROKE OFF. THIS EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE JOURNEY ART INS BCS STD 3-4 RT11. PATIENT'S CURRENT HEALTH STATUS IS FIT AND HEALTHY.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 15426379 ↗InjurySep 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED A REVISION SURGERY IN WHICH THE BI-LATERAL PATELLA WAS REPLACED. AS A STANDARD THE SURGEON DOES A POLY CHANGE THEN AS WELL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7853253 ↗InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO KNEE LUXATION. SURGEON IMPLANTED A NEW INSERT.
Patient problems: Joint Dislocation
MAUDE report 7147288 ↗
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-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
- 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
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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