JOURNEY 74023282Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010555359), received between Aug 23, 2017 and Jun 17, 2024 — classified as 8 injuries.

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

• InjuryJun 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAKAGE OF THE JOURN ART INS BCS STD 7-8 LT10 POST. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE POLY INSERT WAS REPLACED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19554985 ↗
• InjuryOct 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED AROUND 10 YEARS AGO, THE POST OF A JOURN ART INS BCS STD 7-8 LT10 GOT BROKEN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE, IN WHICH THE PATELLA WAS RESURFACED AND THE POLY WAS EXCHANGED. PATIENT IS RECOVERING.

  Patient problems: Failure of Implant

  MAUDE report 17949679 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TKR HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT COMPLAINED OF PAIN. A REVISION WAS PERFORMED AND IT WAS NOTICED THAT THE ORIGINAL JOURNEY I POLY POST HAD BROKEN OFF. JOURNEY TALL POST WAS IMPLANTED IN ITS PLACE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13711559 ↗
• InjuryDec 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, AFTER A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010, THE IMPLANTED JOURNEY ARTICULAR INSERT BCS STANDARD 7-8 LEFT 10MM BROKE. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY CONDUCTED ON (B)(6) 2021. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12911351 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT COMPLAINED OF DISLOCATION. THE INITIAL REPORTER SAID THAT IT WAS CONFIRMED THAT THE JOURN ART INS BCS STD 7-8 LT10 ((B)(4)) WAS TO BLAME FOR THE DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THE ADVERSE EVENT AND ONLY THE INSERT WAS EXPLANTED. IT IS UNKNOWN THE PATIENT'S CURRENT STATUS AND FURTHER INFORMATION IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 12168017 ↗
• InjuryApr 14, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE THE JOURNEY ART INS BCS STANDARD 7-8 LEFT 10 WAS BROKEN AND PATIENT COMPLAINT OF INSTABILITY. THE DEVICE WAS IMPLANTED IN (B)(6) 2007.

  Patient problems: Injury

  MAUDE report 9960458 ↗
• InjuryMar 14, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN INSERT.

  Patient problems: Injury

  MAUDE report 8420786 ↗
• InjuryAug 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO DISLOCATION. SURGEON REPLACED THE FEMUR AND INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6813320 ↗

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