JOURNEY 74023253Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010555151), received between Jul 25, 2018 and Mar 12, 2024 — classified as 6 injuries.

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 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 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED INSTABILITY IN THE KNEE. UPON EXAMINATION, IT WAS NOTICED THAT THE BCS POST OF THE JOURN ART INS BCS STD 5 6 RT11 HAD FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 18887289 ↗
• InjuryAug 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON 2008 ON THE RIGHT SIDE. A BILATERAL REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, DUE TO THE JOURN ART INS BCS STD 5-6 RT11 BROKE. THE CURRENT HEALTH STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15266686 ↗
• InjuryDec 2, 2021Break; Break

  IT WAS REPORTED THAT AFTER A TKA SURGERY HAD BEEN PERFORMED ON 2006, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN AND INSTABILITY DUE TO A BROKEN POST OF THE JOURN ART INS BCS STD 5-6 RT11 AND MALROTATION OF THE TIBIA. THE SYSTEM WAS REPLACED WITH A FULL EXACTECH. IT IS UNKNOWN CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12916527 ↗
• InjuryMar 9, 2021Break; Break

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED, THE PATIENT DISLOCATED A FEW TIMES. A REVISION SURGERY WAS CONDUCTED TO ADDRESS THIS EVENT. THE SURGEON REALIZED THAT THE POST OF JOURN ART INS BCS STD 5-6 RT11 HAD BROKEN, SO IT WAS REMOVED ALONG WITH THE OTHER COMPONENTS. THE CURRENT STATUS OF HEALTH IN THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11447375 ↗
• InjuryOct 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SITTING ON A CHAIR AND UPON RISING HE FELT THAT THE KNEE BECAME UNSTABLE. UPON INSPECTING THE PATIENT INTRAOPERATIVELY IT WAS DISCOVERED THAT THE INSERT WAS FRACTURED. A REVISION SURGERY WAS PERFORMED TO IMPLANT A NEW INSERT.

  Patient problems: Injury

  MAUDE report 9187480 ↗
• InjuryJul 25, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO INSTABILITY. AT TIME OF REVISION SURGERY IT WAS DISCOVERED THE BCS INSERT POST HAD BROKEN.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 7717796 ↗

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