JOURNEY 74023251Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010555137), received between Jun 21, 2017 and Dec 27, 2024 — classified as 28 injuries.

The most frequently reported specific device problem is “Fracture” (14 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY PERFORMED ON 2007, THE POST OF THE JOURN ART INS BCS STD 5-6 RT 9 BROKE OFF. THIS WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2024. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21026805 ↗
• InjuryNov 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE PAIN AND THE POST OF THE POLY INSERT HAD BROKEN OFF. THIS WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JOURN ART INS BCS STD 5-6 RT 9 WAS EXPLANTED AND SWAPPED FOR A CONSTRAINED VERSION OF J2. PATIENT'S CURRENT HEALTH STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20652733 ↗
• InjurySep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER UNDERGOING TKA ON (B)(6) 2012, THE PATIENT BOOKED FOR REVISION DUE TO MECHANISM DISLOCATING ON (B)(6) 2024. THE KNEE WAS REDUCED IN EMERGENCY. DURING REVISION IT WAS NOTED THE JOURN ART INS BCS STD 5-6 RT 9 POST HAD BROKEN FREE AND WAS FLOATING IN THE KNEE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20226744 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2010, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. INSERT WAS EXCHANGED AT THE SAME TIME PATELLA WAS RESURFACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19730921 ↗
• InjuryMar 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCE A KNEE LOCKED UP ABOUT 6 MONTHS AGO, THE KNEE LOCKED UP AT OTHER TIMES DURING SLEEP HE MOVED HIS LEG TO THE WRONG WAY. THIS WAS TREATED WITH REVISION SURGERY ON (B)(6) 2023, IN WHICH UPON REMOVAL, IT WAS NOTICED THE JOURNEY I BCS POST WAS BROKEN AND REPLACED WITH A REV JOURNEY ART INS BCS STD 5 6 RT 10. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 16607404 ↗
• InjuryMar 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON 2008, THE PATIENT EXPERIENCED JOINT INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 FOR A POLY SWAP, DURING WHICH IT WAS NOTICED THAT A POST OF ONE (1) JOURN ART INS BCS STD 5-6 RT 9 WAS BROKEN. PATIENT DID NOT INDICATE HE HAD FALLEN AND WAS OF AVERAGE BMI. PATIENT WAS DISCHARGED THE SAME DAY AND IS OF AVERAGE HEALTH.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16554871 ↗
• InjuryAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JOURNEY ARTICULAR INSERT BCS STANDARD 5-6 RIGHT 9MM WAS REPLACED. THIS DEVICE WAS THE ONLY ONE THAT WAS EXPLANTED. UPON INSPECTION, THE POST WAS FOUND TO BE BROKEN. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15266670 ↗
• InjuryJul 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY AND FELT THAT SOMETHING WAS FLOATING IN THEIR KNEE. A COMPUTED TOMOGRAPHY SHOWED A POSSIBLE PIECE IN THE KNEE JOINT. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022, IN WHICH THE POLY WAS EXPLANTED AND REPLACED WITH A JOURNEY I REVISION POLY; IN ADDITION, THE BROKEN PIECE WAS RETRIEVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15108276 ↗
• InjuryJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED, THE JOURNEY ARTICULAR INSERT BCS STANDARD 5-6 RIGHT BROKE. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant; Pain; Synovitis

  MAUDE report 14983556 ↗
• InjuryMay 19, 2022Fracture; Fracture

  IT WAS REPORTED, AFTER A TKA SURGERY HAD BEEN PERFORMED ON 2010, THE PATIENT COMPLAINT OF PAIN. IT WAS DETERMINED THAT A SMALL BIT OF THE SUPERIOR PART OF THE POST HAD FRACTURE OFF OF THE JOURN ART INS BCS STD 5-6 RT 9. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT, WHERE THE ARTICULAR INSERT WAS EXPLANTED. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14435535 ↗
• InjuryFeb 16, 2022Break; Break

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2008, THE JOURN ART INS BCS STD 5-6 RT 9 BROKE. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022. THE PATIENT IS FIT AND HEALTHY.

  Patient problems: Failure of Implant

  MAUDE report 13542207 ↗
• InjuryFeb 1, 2022Break; Break

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2009, A REVISION SURGERY OF THE JOURNEY ONE BCS RIGHT 5-6 9MM INSERT HAD TO BE PERFORMED ON (B)(6) 2022 DUE TO A BROKEN POST. PATIENT WAS NOT HARMED BEYOND DESCRIBED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 13419058 ↗
• InjuryJul 8, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED AN ITERATIVE DISLOCATION OF THE PROSTHESIS APPEARED IN FLEXION. IT IS BELIEVED A JOURN ART INS BCS STD 5-6 RT 9 HAS BROKEN. THIS ADVERSE EVENT WILL BE SOLVED THROUGH REVISION SURGERY TO REPLACE THE INSERT, APPROXIMATELY IN THE BEGINNING OF (B)(6) 2021. THE PATIENT IS WEARING A RIGID SPLINT AT ALL TIMES MEANWHILE AS THIS PROBLEM PREVENTS THE KNEE FROM BUCKING.

  Patient problems: Failure of Implant

  MAUDE report 12135803 ↗
• InjuryJul 5, 2021Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2010, THE PATIENT STARTED TO EXPERIENCE PAIN ON THE KNEE AND IT FELT UNSTABLE. THE PATIENT DID NOT SUFFERED ANY INJURY OR ACCIDENT. ON A REVISION SURGERY, PERFORMED ON (B)(6) 2021 IT WAS DETERMINED THAT THE JOURNEY ARTICULAR INSERT BCS STANDARD 5-6 RIGHT 9MM BROKE OFF, SO IT WAS RETRIEVED AND A REVISION JOURNEY ARTICULAR INSERT BCS STD 5-6 RT 9MM WAS INSERTED AS A REPLACEMENT. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12119163 ↗
• InjuryJun 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA-BCS CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2009 (BILATERAL PATIENT), THE PATIENT EXPERIENCED THE FRACTURE OF THE TIBIAL INSERT AND SYNOVITIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT; THE INSERT WAS EXPLANTED. THE PATIENT WAS DISCHARGED A DAY LATER IN OVERALL GOOD CONDITION.

  Patient problems: Discomfort; Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 12080485 ↗
• InjuryApr 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT KNEE BECOME UNSTABLE. SURGEON FOUND THE TIBIAL POST ON THE TIBIAL INSERT HAD FRACTURED OFF. THE JOURN ART INS BCS STD 5-6 RT 9 AND BROKEN POST WERE REMOVED. NEW JOURNEY BCS POLY WITH THE TALLER POST WAS INSERTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity

  MAUDE report 11616775 ↗
• InjuryOct 15, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY I BCS COMPONENT JUMP THE POST YEARS AGO, AFTER IMPLANTATION. THEREFORE, THE SURGEON RELOCATED THE KNEE. ACCORDING TO THE SURGEON AFTER THE PROCEDURE, THE PATIENT WAS DOING FINE. SUBSEQUENTLY, THE PATIENT JUMPED THE POST AGAIN 3-4 WEEKS AGO, SO THE SURGEON OPENING THE KNEE AND IT WAS FOUND THE TIP OF THE POST HAS BROKEN OFF. CONSEQUENTLY, THE POLY AND BROKEN PIECES WERE REMOVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10686437 ↗
• InjuryAug 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT PATIENT PRESENTED AN UNSTABLE KNEE. A REVISION SURGERY WAS PERFORMED AND POST WAS FOUND TO BE BROKEN ON THE 5-6 9MM BCS POLY. IMPLANT WAS REPLACED WITH A 11MM BCS POLY.

  Patient problems: Injury

  MAUDE report 10368586 ↗
• InjuryJun 4, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A DISLOCATION, PATIENT REQUIRED A REVISION SURGERY TO REPLACE THE BROKEN POST ON THE INSERT. ALL PIECES WERE RECOVERED AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10118577 ↗
• InjuryMar 12, 2020Break; Break

  IT WAS REPORTED THAT REVISION SURGERY HAD TO BE PERFORMED 9 YEARS AFTER PRIMARY SURGERY DUE TO THE BREAKAGE OF THE POST OFF OF JOURNEY ART INS BCS STANDARD 5-6 RIGHT 9. THE REASON FOR THE WRECKAGE IS NOT KNOWN.

  Patient problems: Injury

  MAUDE report 9824719 ↗
• InjuryMar 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INSTABILITY ON THE RIGHT KNEE AFTER PRIMARY TKR WAS PERFORMED. NO FALLS WERE REPORTED PRIOR TO THE EVENT. THE PATIENT UNDERWENT REVISION SURGERY TO CHANGE THE ARTICULAR INSERT FROM 9 MM TO 15 MM. THE INSERT WAS FOUND TO HAVE ITS BASE SEPARATED FROM THE IMPLANT.

  Patient problems: Injury

  MAUDE report 9776434 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BROKEN POST OF JOURNEY I INSERT.

  Patient problems: Injury

  MAUDE report 8839765 ↗
• InjuryMay 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 8604132 ↗
• InjuryApr 14, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED TO REMOVE THE INSERT BECAUSE IT WAS BROKEN.

  Patient problems: Injury

  MAUDE report 8512570 ↗
• InjuryApr 11, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PRIMARY INSERT BROKE IN THE PATIENT AFTER 10 YEARS. NO MORE INFORMATION PRESENTED.

  Patient problems: Injury

  MAUDE report 8505354 ↗

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-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-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