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JOURNEY 74023272Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY ARTICULAR INSERT BCS STANDARD 7-8 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 03596010555281), received between May 21, 2018 and Dec 6, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (3 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture3
  • Break1
  • Material Fragmentation1

Patient problems

  • Failure of Implant4
  • Joint Dislocation1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 6, 2024Fracture; Fracture

    IT WAS REPORTED THAT, AFTER A TKR PERFORMED ON (B)(6) 2012, PATIENT WAS WALKING DOWNSTAIRS AND NOTICED INESTABILITY IN THE TKR. WHEN DOCTOR OPENED THE KNEE, THE JOURN ART INS BCS STD 7-8 RT10 WAS BROKEN. THIS ADVERSE EVENT WAS TREATED BY REMOVING THE BROKEN POST AND INSERTING A REV JOURNEY ART INS BCS STD 7-8 RT 9 ON AN UNKNOWN DATE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 20873271 ↗
  • InjuryApr 7, 2024Fracture; Fracture

    IT WAS REPORTED THAT, AFTER A TKA PROCEDURE PERFORMED ON (B)(6) 2010, THE POST OF A JOURNEY ARTICULAR INSERT BCS STANDARD 7-8 RIGHT 10MM BROKE OFF. A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2024 TO ADDRESS THIS EVENT. FURTHER COMPLICATIONS WERE NOT REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 19057129 ↗
  • InjuryJul 7, 2022Fracture; Fracture

    IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE DISLOCATION, FURTHER INVESTIGATION REVEALED THE PATIENT HAD A BROKEN POLY COMPONENT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

    Patient problems: Failure of Implant

    MAUDE report 14952078 ↗
  • InjuryMar 2, 2022Break; Break

    IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAK FROM THE POST. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION ON (B)(6) 2022 TO EXCHANGED AND EXPLANTED THE JOURN ART INS BCS STD 7-8 RT10 DUE TO BROKEN POST. CURRENT HEALTH STATUS OF PATIENT WAS REPORTED AS FIT AND HEALTHY.

    Patient problems: Failure of Implant

    MAUDE report 13654044 ↗
  • InjuryMay 21, 2018Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT THE PATIENT DISLOCATED THE FEMORAL COMPONENT OVER POST IN HIGH FLEXION. THE SURGEON FOUND THE TIP OF INSERT HAD BROKEN OFF AND WAS FLOATING FREE IN KNEE. THE INSERT WAS REMOVED AND REPLACED.

    Patient problems: Joint Dislocation

    MAUDE report 7530751 ↗

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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