JOURNEY 74022226Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010554345), received between Nov 30, 2017 and May 19, 2021 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND SWELLING FROM INFECTION. A PREVIOUS WASHOUT AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2021. AFTER THIS PROCEDURE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE JOURNEY TIBIA BASE NP LT SZ 6 WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 11849088 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LEFT KNEE REVISION SURGERY WAS PERFORMED BECAUSE OF AN INFECTION WITH ENTEROCOCCUS FAECALIS. THE FEMORAL COMPONENT, THE ARTICULAR INSERT AND THE TIBIAL BASE PLATE WERE EXPLANTED. THE INFECTION WAS TREATED WITH VANCOMYCIN AND METRONIDAZOLE. THE OUTCOME OF THE PROCEDURE IS RESOLVED, WITH RESIDUAL EFFECT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10503179 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT DEVELOPED AN INFECTION IN THE RIGHT TKA. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10474393 ↗
• InjuryJul 3, 2020Adverse 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 THE LOOSENING OF FEMORAL COMPONENT AND PAIN. PRIMARY OPERATION WAS PERFORMED ON (B)(6) 2019. THERE WAS NO PROBLEM AT THAT TIME, AND THERE WAS NO FINDINGS OF INFLAMMATION LIKE ARTHROFIBROSIS, NOR INFECTION. ON (B)(6) 2020 REVISION SURGERY WAS PERFORMED AND FEMORAL COMPONENT, TIBIAL COMPONENT, INSERT AND PATELLA WERE REMOVED. THE FEMORAL COMPONENT WAS EASY TO REMOVE, BUT THE OTHER COMPONENTS WERE FIXED WELL. THERE WAS A LITTLE RESIDUE OF CEMENT ONTO NON-ARTICULAR SURFACE OF FEMORAL COMPONENT. PATIENT OUTCOME IS GOOD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 10230723 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT DEVELOPED AN INFECTION. THE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY: THE JOURNEY II TIBIAL BASEPLATE WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10065178 ↗
• InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8458784 ↗
• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO INFECTION AND PAIN. NO ADDITIONAL DETAILS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8458322 ↗
• InjuryMar 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN ALONG WITH SNAPPING AND GRINDING OVER THE ANTEROLATERAL ASPECT OF THE KNEE.

  Patient problems: Pain

  MAUDE report 8420997 ↗
• InjuryMar 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REMAINING LOSS OF FUNCTION AND LIMITED FLEXION AND EXTENSION AFTER TKA LEFT. SUBJECT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8395630 ↗
• InjuryFeb 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ELEVATED WHITE CELL COUNT IN LEFT JOINT FLUID POST-OP ¿ POSSIBLE INFECTED JOINT REPLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 8365016 ↗
• InjuryMar 27, 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 LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 7375015 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO A SUBLUXED DISLOCATED LEFT PATELLA.

  Patient problems: Joint Dislocation

  MAUDE report 7137740 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH FLEXION CONTRACTURE AND UNDERWENT A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069962 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, 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