JOURNEY 74023271Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY ARTICULAR INSERT BCS STANDARD 7-8 RIGHT 9MM · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010555274), received between Oct 18, 2017 and Nov 19, 2025 — classified as 19 injuries.
The most frequently reported specific device problem is “Break” (7 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
- Fracture6
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
- Material Deformation1
- Patient Device Interaction Problem1
- Unintended Movement1
Patient problems
- Failure of Implant7
- Injury6
- Insufficient Information2
- Discomfort1
- Hemorrhage/Blood Loss/Bleeding1
- Joint Laxity1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Fracture; Fracture
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE POST OF A JOURN ART INS BCS STD 7-8 RT 9 BROKE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE JOURN ART INS BCS STD 7-8 RT 9 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23594521 ↗InjuryMar 20, 2025Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT HAD AN UNSTABLE FEELING OF THE RIGHT KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JOURN ART INS BCS STD 7-8 RT 9 WAS EXCHANGED DUE TO A BROKEN POST. PATIENT'S CURRENT HEALTH STATUS IS HEALTHY.
Patient problems: Joint Laxity
MAUDE report 21651775 ↗InjuryMar 7, 2025Fracture; Fracture
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT HAD A BROKEN INSERT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JOURN ART INS BCS STD 7-8 RT 9 WAS EXPLANTED AND REPLACED. PATIENT'S CURRENT HEALTH STATUS IS GOOD FOR HIS AGE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 21547844 ↗InjuryAug 31, 2024Degraded; Degraded
IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT POTENTIALLY EXPERIENCED UNKNOWN ADVERSE EVENTS. THIS WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE POLY WAS EXCHANGED FOR ONE (1) JOURN ART INS BCS STD 7-8 RT 9 WHICH WAS INSERTED INTO ONE (1) JOURNEY TIBIA BASE NP RT SZ 8. THE POST OF THE POLY APPEARED WORN AND DAMAGED PROXIMALLY. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20114237 ↗InjuryMar 24, 2022Break; Break
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED COMPLETELY BREAK POST FROM THE POLY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE JOURN ART INS BCS STD 7-8 RT 9. THE SURGEON WAS ABLE TO RECOVERED TWO MAIN PIECES AND SOME SMALL FRAGMENTS FROM THE BROKEN POST. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 13876895 ↗InjuryNov 15, 2021Break; Break
IT WAS REPORTED THAT, AFTER AN ARTHROSCOPY SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY. UPON CLOSER INSPECTION, THE POST WAS FOUND TO BE BROKEN. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2021. THE BROKEN INSERT WAS REPLACED WITH A JOURNEY BCS REVISION ARTICULAR INSERT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN, ALTHOUGH SURGEON IS VERY HAPPY WITH THE SURGICAL OUTCOME.
Patient problems: Failure of Implant
MAUDE report 12815100 ↗InjurySep 29, 2021Break; Break
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED BREAKAGE OF THE JOURN ART INS BCS STD 7-8 RT 9. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH THE JOURN ART INS BCS STD 7-8 RT 9 WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Discomfort; Failure of Implant
MAUDE report 12550900 ↗InjurySep 10, 2021Break; Break
IT WAS REPORTED THAT, AN UNKN JOURNEY KNEE IMPL WAS BROKEN ON INSERT WHICH REQUIRED A REVISION CASE TO CORRECT. ALL PIECES WERE RECOVERED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 12453037 ↗InjuryAug 17, 2021Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem
IT WAS REPORTED THAT, IN ORDER TO ALLEVIATE PATELLA PAIN, A REVISION SURGERY WAS PERFORMED. THE SURGEON MAKE A RESURFACING OF THE PATELLA AND PUT A PATELLAR IMPLANT. ALSO, ON THE DAY OF THE SURGERY, THE SURGEON DECIDED TO EXCHANGE THE JOURN ART INS BCS STD 7-8 RT 9 DUE TO IT WAS FOUND BROKEN WHEN THE KNEE WAS EXPOSED. NO APPARENT HEALTH CONSEQUENCES WERE REPORTED.
Patient problems: Pain
MAUDE report 12331621 ↗InjuryOct 22, 2020Fracture; Fracture
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE JOURNEY ART INS BCS STANDARD 7-8 RIGHT 9. NO INFORMATION ABOUT THE PATIENT STATUS WAS INITIALLY PROVIDED.
Patient problems: Failure of Implant
MAUDE report 10722289 ↗InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER SURGERY, RIGHT TKR, THE PATIENT SUFFERED FROM DISCOMFORT AND REPETITIVE BLEEDING EPISODES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 9820359 ↗InjuryMar 5, 2020Fracture; Fracture
IT WAS REPORTED THAT AFTER SURGERY, RIGHT TKR, THE PATIENT SUFFERED FROM PAIN, DISCOMFORT AND REPETITIVE BLEEDING EPISODES. ARTHROSCOPIC EXAMINATION AND KNEE DEBRIDEMENT WERE PERFORMED WITH NO INFECTION CONFIRMED, THIS PROVIDING ONLY TEMPORAL RELIEF, RESULTING IN REVISION SURGERY DUE TO POLY BREAKAGE.
Patient problems: Injury
MAUDE report 9795125 ↗InjuryMar 20, 2019Unstable; Unstable
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. RIGHT TKR POLY WAS EXCHANGED.
Patient problems: Injury
MAUDE report 8436618 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A POLY SWAP ON PATIENT OF A JOURNEY 1 IMPLANT. CUSTOMER ASKED FOR REVISION DUE TO GENUFLECTING KNEE. SURGEON DECIDED TO MAKE AN EX - CHANGE OF THE IMPLANT, WHILE DOING IT POST BROKE OFF INSERT. NO DELAY. BACK UP DEVICE OF S&N USED.
Patient problems: Injury
MAUDE report 8297027 ↗InjuryJan 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE INSERT DUE TO UNSPECIFIED DAMAGE.
Patient problems: Injury
MAUDE report 8207390 ↗InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BROKEN COMPONENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7646087 ↗InjuryMay 4, 2018Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE POLYETHYLENE POST HAD BROKEN OFF INTO THE FEMORAL COMPONENT.
Patient problems: Injury
MAUDE report 7488831 ↗InjuryNov 20, 2017Fracture; Fracture
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY TO EXCHANGE A BROKEN TIBIAL LINER, WITH BREAKAGE OF THE LINER'S POST.
Patient problems: Failure of Implant
MAUDE report 7044598 ↗InjuryOct 18, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE CLICKING NOISE IN THE KNEE. THE POLY WAS REMOVED.
Patient problems: Injury
MAUDE report 6958926 ↗
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-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
- 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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