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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

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: 0 reportsSep 2024: 0 reportsOct 2024: 1 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

  • 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, Classified
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
  • 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
  • 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

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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