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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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, Classified
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
  • Z-0002-2019 · Jun 13, 2018 · Open, Classified
    JOURNEY 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, Classified
    JOURNEY 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, Classified
    Journey 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

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Sources and updates

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