JOURNEY 74023283Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010555366), received between Jul 28, 2019 and Mar 31, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED PAIN. THIS WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE PEG ON THE JOURNEY ARTICULAR INSERT STANDARD 7-8 LEFT 11MM WAS FOUND TO BE BROKEN. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 16657377 ↗
• InjuryJan 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY WAS PERFORMED ON (B)(6) 2008, THE PATIENT REPORTED SUDDEN LOSS OF STABILITY DURING A TENNIS MATCH. FURTHERMORE, ANAMNESTIC EXAMINATION INDICATED A POSSIBLE FRACTURE OF THE IMPLANT'S POST. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JOURN ART INS BCS STD 7-8 LT11 WAS EXCHANGED. INTRAOPERATIVELY, THE POST BREAKAGE OF THE ARTICULAR INSERT WAS CONFIRMED AND SIGNIFICANT POLYETHYLENE WEAR WHICH HAD LED TO FIRST SIGNS OF SYNOVITIS WAS ALSO IDENTIFIED. PATIENT IS CURRENTLY IN A HEALTHY CONDITION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Laxity; Synovitis

  MAUDE report 16187768 ↗
• InjuryJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED A POST BREAKAGE OF THE JOURNEY ART INS BCS STD 7 8 LT11. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE INSERT WITH A JOURNEY 7/8 13MM REVISION INSERT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15070668 ↗
• InjuryJul 3, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE POST OF A INSERT BROKE. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE INSERT WITH A JOURNEY REVISION HIGH POST POLY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10228615 ↗
• InjuryAug 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED TO PERFORM A POLY EXCHANGE, DUE TO THE PATIENT SUFFERING A DISLOCATION. ADDITIONALLY, A FRAGMENT OF THE POST BROKE OFF SO IT WAS REMOVED FROM THE KNEE AND REPLACED WITH A JOURNEY HIGH POST.

  Patient problems: Joint Dislocation

  MAUDE report 8881925 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A JOURNEY I TOTAL KNEE SYSTEM WAS PUT INTO PATIENT ON (B)(6) 2007. PATIENT RECENTLY CAME TO SURGEON COMPLAINING OF ¿CLICKING¿ NOISE. SURGEON SCHEDULED POLY EXCHANGE. UPON INCISION, IT WAS FOUND THAT THE POST ON THE ARTICULAR INSERT HAD BROKEN OFF. NO MORE INFORMATION WAS PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8834700 ↗

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