JOURNEY 74023281Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010555342), received between Jan 8, 2020 and Dec 24, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (6 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED PAIN AND INSTABILITY. UPON EXAMINING PATIENT THE CURRENT SURGEON FOUND AP INSTABILITY AND TALKING TO ORIGINAL SURGEON THEY ESTABLISHED THE POST OF ONE (1) JOURN ART INS BCS STD 7-8 LT 9 IS WORN/BROKEN.THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JOURN ART INS BCS STD 7-8 LT 9, ONE (1) GNS II RESURF PAT 35 MM, AND ONE (1) JOUR FEM COCR NP LT SZ 7 WERE EXPLANTED. ADDITIONALLY, ONE (1) REV JOURNEY ART INS BCS STD 7-8 LT 9 AND ONE (1) GNS II RESURF PAT 35 MM WERE IMPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23887963 ↗
• InjuryFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED A BREAKAGE OF THE JOURN ART INS BCS STD 7-8 LT 9 POST. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18692505 ↗
• InjuryJan 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON 2007, THE PATIENT EXPERIENCED PAIN AND INSTABILITY. ON (B)(6) 2023, THE PATIENT WAS ADMITTED AND X-RAYS SHOWED THE KNEE BEING DISLOCATED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6)2023, IN WHICH AN UNKN JOURNEY BCS KNEE INSERT WAS EXCHANGED. UPON REMOVING THE OLD INSERT, IS WAS EVIDENT THAT THE POST HAD BROKEN, ALLOWING THE FEMUR TO JUMP ANTERIORLY. PATIENT HAD NO ADVERSE REACTION AND SURGEON WAS HAPPY AND KNEE STABLE AFTER INSERT INSERTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Implant Pain; Joint Dislocation

  MAUDE report 18536174 ↗
• InjurySep 19, 2023Material Deformation; Material Deformation

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

  Patient problems: Failure of Implant; Inadequate Osseointegration; Osteolysis

  MAUDE report 17775334 ↗
• InjuryJun 30, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT AFTER A TOTAL KNEE ARTHROPLASTY ON THE LEFT KNEE USING JOURNEY SYSTEM WAS PERFORMED ON (B)(6) 2009 DUE TO ARTHRITIS THE PATIENT STARTED TO DEVELOP INSTABILITY. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH A FIXED DISLOCATION OF THE LEFT KNEE THAT REQUIRED CLOSED REDUCTION. AFTERWARD, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2021. DURING THE REVISION SURGERY, THE INSERT WAS EXPLANTED AND NOTICED FRACTURE JUST AT THE MIDPOINT OF THE DEVICE. A NEW INSERT WAS IMPLANTED, AND THE REST OF THE JOURNEY SYSTEM REMAIN IMPLANTED. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Foreign Body Reaction; Joint Dislocation

  MAUDE report 17243269 ↗
• InjuryDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, A PATIENT HAD AN UNSTABLE LEFT KNEE, SO A REVISION SURGERY WAS BOOKED ON THE (B)(6) 2022 TO EXPLANT ONE (1) JOURNAL ART INS BCS STD 7-8 LT 9 WHICH HAD A POST BROKEN. A 7/8 13MM JOURNEY I WAS INSERTED IN EXCHANGE. NO DELAY REPORTED. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Failure of Implant

  MAUDE report 15946243 ↗
• InjuryOct 26, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2008 , THE PATIENT EXPERIENCED A DISLOCATION OF THE KNEE AND INSTABILITY, DURING SURGERY IT BECAME CLEAR THAT THE JOURN ART INS BCS STD 7-8 LT 9 WAS BROKEN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 12699126 ↗
• InjuryJul 23, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT SUDDENLY EXPERIENCED INSTABILITY IN FLEXION, SO A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXPLANT THE INSERT TO A NEW ONE. IT WAS NOTICED THAT THE POST HAD FRACTURED AT THE TIP. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 10317324 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY, LEFT TKR, THE PATIENT SUFFERED FROM DISCOMFORT AND REPETITIVE BLEEDING EPISODES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9795128 ↗
• InjuryFeb 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS WALKING WITH A BRACE AND WAS DISLOCATING THE KNEE ACTIVELY. THE EVENT RESULTED IN REVISION SURGERY TO REMOVE THE INSERT. IT WAS FOUND THAT THE UPPER TIP OF THE POST OF THE BCS INSERT HAD BROKEN OFF.

  Patient problems: Injury

  MAUDE report 9770374 ↗
• InjuryJan 8, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT. LATER, THE PATIENT REPORTED ANTERIOR KNEE PAIN AND A FEELING OF GIVING AWAY (ESPECIALLY DOWNSTAIRS). THE DOCTOR PERFORMED A KNEE ARTHROSCOPY AND IDENTIFIED THAT THE POST OF THE POLY HAD SNAPPED. THEREFORE, THE LOOSE REMAINING TIP OF THE POST WAS REMOVED ARTHROSCOPICALLY. THE PATIENT WAS LATER BOOKED AND HAD REVISION SURGERY FOR AN INSERT/POLY EXCHANGE ON (B)(6) 2019. NO OTHER COMPONENTS WERE REVISED. NO OPERATIVE REPORTS ARE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9566699 ↗

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