JOURNEY 74023264Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010555236), received between Mar 25, 2021 and Feb 12, 2024 — classified as 8 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED BROKEN POLY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JOURN ART INS BCS STD 5-6 LT13 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 18684455 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT PRESENTED AN UNSTABLE KNEE. THIS WAS RESOLVED VIA A REVISION SURGERY ON (B)(6) 2023 DURING WHICH A SIZE 5-6 13MM JOURNEY L BCS LEFT POLYMER INSERT WAS EXPLANTED AND REPLACED WITH A SIZE 5-6 JOURNEY LL LEFT BCS POLYMER INSERT. THE PATIENT WAS STABLE ON THE TABLE.

  Patient problems: Joint Laxity

  MAUDE report 18119731 ↗
• InjuryFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED APPROXIMATELY 12 YEARS AGO, THE SURGEON ADVISED THAT A REPLACEMENT OF ONE (1) JOURN ART INS BCS STD 5-6 LT13 WAS PROBABLY REQUIRED DUE TO POSSIBLE TOTAL OR PARTIAL RUPTURE OF THE POSTERIOR STABILIZATION PAD OF THE POLYETHYLENE INSERT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. DURING THIS PROCEDURE, THE FRACTURE OF THE INSERT WAS CONFIRMED. THIS PROSTHESIS WAS REPLACED ALONG WITH A PATELLAR REPLACEMENT AS THE PATIENT PRESENTED PAIN AT THIS LEVEL. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant; Joint Laxity

  MAUDE report 16415107 ↗
• InjuryAug 16, 2022No Apparent Adverse Event; No Apparent Adverse Event

  BILATERAL PATIENT. IT WAS REPORTED THAT, FOLLOWING A BILATERAL TKA CONSTRUCT HAD BEEN IMPLANTED ON PATIENT'S BOTH KNEES ON (B)(6) 2010, THE PATIENT EXPERIENCED A RIGHT KNEE INSERT POST BREAKAGE THAT REQUIRED A REVISION SURGERY ON (B)(6) 2021 AND IS NOW FEELING ANXIOUS AND CONCERNED FOR THE POSSIBILITY OF HIS LEFT KNEE INSERT HAVING THE SAME OUTCOME. THE PATIENT IS LOOKING FOR AN ELECTIVE POLYETHYLENE EXCHANGE DESPITE HIS HEALTH CONDITION BEING REPORTED AS FAIRLY GOOD. THIS PROCEDURE HAS BEEN SCHEDULED FOR (B)(6) 2022.

  Patient problems: Anxiety

  MAUDE report 15237802 ↗
• InjuryFeb 24, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A SYSTEMIC INFECTION WHERE HIS KNEE ASPIRATE HAD A WHITE COUNT OF 160K. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022 THE POLY WAS REMOVED AND FOUND TO HAVE A BROKEN POST A NEW POLY WAS INSERTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 13591706 ↗
• InjuryJan 10, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, A POST OF THE JOURN ART INS BCS STD 5-6 LT13 BROKE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH THE BROKEN DEVICE WAS REPLACED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13205833 ↗
• InjuryDec 8, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT, AFTER A KNEE SURGERY HAD BEEN PERFORMED, THE JOURN ART INS BCS STD 5-6 LT13 WAS WORN AND FRACTURED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12964818 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY TKA SURGERY, PATIENT PRESENTED AS A LITTLE UNSTABLE, AND REVISION SURGERY WAS PERFORMED TO REMOVE THE JOURNEY ARTICULAR INSERT BCS STANDARD 5-6 LEFT 13MM. THE POLY WAS REPLACED WITH A 15MM CONSTRAINED POLY. THE PATIENT WAS STABLE ON TABLE. ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Joint Laxity

  MAUDE report 11568074 ↗

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