JOURNEY 74023262Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010555212), received between Apr 19, 2018 and Sep 8, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2022Unstable; Unstable

  IT WAS REPORTED THAT, AFTER A TKR SURGERY, THE PATIENT EXPERIENCED INSTABILITY. A REVISION SURGERY WAS PERFOMED ON THE (B)(6) 2022 TO THREAD THIS ADVERSE EVENT, IN WHICH A JOURN ART INS BCS STD 5-6 LT10 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15384971 ↗
• InjuryJan 3, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON 2006, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE A BROKEN JOURNEY ARTICULAR INSERT BCS STD 5-6 LT 10MM. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13142458 ↗
• InjuryNov 25, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED ON 2010, THE JOURN ART INS BCS STD 5-6 LT10 BROKE ON (B)(6) 2021. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2021 TO EXPLANT THE JOURN ART INS BCS STD 5-6 LT10 AND PATELLA RESURFACING. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12874481 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S LEFT KNEE ON (B)(6) 2011 (BILATERAL PATIENT), THE PATIENT EXPERIENCED PAIN, INSTABILITY, SWELLING, MECHANICAL SYMPTOMS AND APNEA EPISODES. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THE ADVERSE EVENT; THE POLYETHYLENE INSERT WAS EXPLANTED, ALTHOUGH IT IS UNKNOWN IF ANY OF THE REMAINING COMPONENTS FROM THE CONSTRUCT WERE EXPLANTED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Apnea; Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12085383 ↗
• InjuryFeb 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO EXPLANT A JOURNEY I INSERT. THE INSERT WAS FOUND TO BE BROKEN ON X-RAYS.

  Patient problems: Injury

  MAUDE report 9754047 ↗
• InjuryNov 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM A BROKEN INSERT.

  Patient problems: Injury

  MAUDE report 9313367 ↗
• InjuryApr 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2019, WHILE THE PATIENT WAS ON RISING FROM SITTING POSITION FELT A CLUNK AND THE KNEE LOCKED OUT BUT WAS ABLE TO UNLOCK. ON (B)(6) 2019 THE KNEE LOCKED OUT AGAIN AND THIS TIME REMAINED LOCKED. ON (B)(6) 2019 THE PATIENT WENT THROUGH A REVISION SURGERY FOR REMOVAL AND REPLACEMENT OF THE ARTICULAR INSERT.

  Patient problems: Injury

  MAUDE report 8504689 ↗
• InjuryMar 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO INFECTION. INSERT EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 8406522 ↗
• InjuryFeb 19, 2019Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO INSTABILITY. INSERT WAS FOUND BROKEN. NO DELAY OR ADDITIONAL INJURIES REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8351456 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY FOR THE RIGHT KNEE AND DISLOCATION OF INSERT FOLLOWING FALL.

  Patient problems: Joint Dislocation

  MAUDE report 7445386 ↗

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