JOURNEY 74023231Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010554994), received between Dec 27, 2017 and Oct 9, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE POST OF THE JOURN ART INS BCS STD 3-4 RT 9 BROKE. A REVISION SURGERY WAS PERFORMED ON 11-SEP-2025 TO EXCHANGE THE IMPLANT. THE PATIENT NEEDED TO BE KEPT IN THEATRE FOR ADDITIONAL TIME DUE TO UNKNOWN REASONS, SO ADDITIONAL ANESTHESIA WAS REQUIRED. THE CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23253583 ↗
• InjuryNov 25, 2024Break; Break

  IT WAS REPORTED THAT, AFTER A TKA IN BOTH KNEES, THE PATIENT SUFFERED FROM BILATERAL INSTABILITY AND KNEE PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY OF THE RIGHT SIDE ON (B)(6) 2024 IN WHICH THE JOURN ART INS BCS STD 3-4 RT WAS EXPLANTED DUE TO BROKEN AND WORN POST. IT WAS ALSO FOUND THAT THE PATIENT HAS PROGRESSION OF OSTEOARTHRITIS OF THE PATELLA. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthritis; Failure of Implant; Joint Laxity

  MAUDE report 20775854 ↗
• InjuryDec 6, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, THE PATIENT EXPERIENCED SYMPTOMS OF ANTERIOR KNEE PAIN IN NOVEMBER CAUSED BY PATELLA WEAR. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, TO RESURFACE THE PATELLA AND EXCHANGE THE POLY INSERT. KNEE HAD DISLOCATED AND WAS REDUCED AT BASE. UPON OPENING RIGHT KNEE IT WAS FOUND THAT THE PS POST OF THE JOURN ART INS BCS STD 3-4 RT 9 WAS BROKEN. PATIENT CURRENT HEALTH STATUS IS OK.

  Patient problems: Arthralgia; Failure of Implant; Joint Dislocation

  MAUDE report 18275757 ↗
• InjuryMar 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER A RIGHT TOTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2010 DUE TO OSTEOARTHRITIS, THE PLAINTIFF EXPERIENCED ACUTE THROBBING KNEE PAIN AT THE MOMENT SHE WAS ATTEMPTING TO EXIT THE BATHTUB. THE PAIN WAS SO SEVERE THAT THE PATIENT HAD DIFFICULTY WALKING. IT WAS NOTICED THAT WHEN EXTENDING THE KNEE THERE WAS A VISIBLE CLUNK WITH SEVERE MID-FLEXION INSTABILITY. A REVISION SURGERY WAS PERFORMED TO SOLVE THESE ADVERSE EVENTS ON (B)(6) 2023, ALL THE COMPONENTS (JOURNEY TIBIA BASE NP RT SZ 4, JOURNEY FEMORAL OXINIUM NONPOROUS BCS RIGHT SIZE 6, JOURNEY BCS PATELLA RESURFACING ROUND 29 MM STANDARD AND JOURNEY ARTICULAR INSERT BCS STANDARD 3-4 RIGHT 9MM) WERE EXPLANTED AND REPLACED WITH AN STRYKER SYSTEM. DURING SURGERY, IT WAS NOTICED THAT THE POST HAD BEEN DEFORMED AND FLIPPED ANTERIORLY. IN ADDITION, THERE WAS SEVERE OXIDATION OF THE MEDIAL AND LATERAL POLYETHYLENE LINER WITH YELLOWING OF BOTH. THERE WERE NO COMPLICATIONS IN THE SURGERY, THE PLAINTIFF WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 16570474 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PROSTHESIS CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT KNEE ON (B)(6) 2007, THE PATIENT REQUIRED A REVISION SURGERY TO EXCHANGE THE JOURN ART INS BCS STD 3-4 RT 9 TO A JOURN ART INS BCS STD 3-4 RT13. A JRNY BCS PAT RESRF RD 32 MM STD PATELLA WAS ALSO IMPLANTED. ANY CLINICAL SYMPTOMS AND/OR COMPLICATIONS THAT MADE NECESSARY THIS INTERVENTION ARE NOT KNOWN.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 15116800 ↗
• InjuryMay 5, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2010, THE JOURN ART INS BCS STD 3-4 RT 9 BROKE. THE PATIENT IS IN PAIN AND IMPACTED BY THE COMPLICATION. A PARTIAL REMOVAL OF THE BROKEN PART WAS PERFORMED UNDER ARTHROSCOPY IN EARLY (B)(6) 2022. A REVISION SURGERY DATE IS TO BE SET TO REPLACE THE INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 14292131 ↗
• InjuryApr 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2008, THE JOURN ART INS BCS STD 3-4 RT 9 FRACTURE. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14233048 ↗
• MalfunctionOct 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE JOURN ARTICULAR INSERT BCS STD 3-4 RT 9. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 10624623 ↗
• InjuryJul 6, 2020Break; Break

  IT WAS REPORTED THAT THE POST ON THE JOURNEY 1 POLY BROKE DUE TO THIS EVENT A REVISION SURGERY WAS CONDUCTED.

  Patient problems: Injury

  MAUDE report 10232490 ↗
• InjuryJun 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE POST OF A JOURNEY ARTICULAR INSERT BCS BROKE. A REVISION SURGERY WAS PERFORMED TO ADDRESS THIS PROBLEM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10178481 ↗
• InjuryFeb 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT PRESENTS SUBLUXATION. REVISION SURGERY IS SCHEDULED TO BE PERFORMED ON (B)(6) 2020.

  Patient problems: Injury

  MAUDE report 9702644 ↗
• InjuryJan 14, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A DURING A TKA PROCEDURE, REVISION SURGERY WAS PERFORMED AND THE ARTICULAR INSERT POST WAS FOUND TO BE DAMAGED. NO DELAY REPORTED. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: Injury

  MAUDE report 8245644 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS TO RELIEVE JOINT IMMOBILIZATION.

  Patient problems: Injury

  MAUDE report 7697391 ↗
• InjuryDec 27, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED WHEN THE SURGEON DISCOVERED THE INSERT DAMAGED AND PARTLY REMOVED. THE INSERT WAS REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 7149602 ↗

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-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
• 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