JOURNEY 74022223Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 03596010554314), received between Oct 25, 2017 and Oct 22, 2025 — classified as 38 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, AFTER IMPLANTATION OF THE FEMORAL COMPONENT AND ONE (1) JOURNEY TIBIA BASE NP LT SZ 3, AND ALLOWING THE CEMENT TO HARDEN WITH A TRIAL INSERT, THE SURGEON ATTEMPTED TO IMPLANT THE FINAL INSERT. THE INSERT COULD NOT BE SEATED INTO THE TIBIAL BASE. MULTIPLE INSERTS WERE TRIED WITHOUT SUCCESS. UPON INSPECTION, IT WAS DISCOVERED THAT THE JOURNEY TIBIA BASE NP LT SZ 3 WAS MISSING THE LOCKING DETAIL, PREVENTING ANY INSERT FROM ENGAGING. AS A RESULT OF THE SURGICAL DELAY, ADDITIONAL ANESTHESIA WAS REQUIRED. THE PROCEDURE WAS ULTIMATELY COMPLETED AFTER A SIGNIFICANT DELAY BY REMOVING THE JOURNEY TIBIA BASE NP LT SZ 3 AND REVISING THE TIBIAL COMPONENT USING LEGION REVISION INSTRUMENTS AND IMPLANTS. THE PATIENT HAD SOME POSTOPERATIVE HYPOTENSION AND STAYED IN THE HOSPITAL ANOTHER 24 HOURS LONGER THAN SHE MIGHT HAVE IF THIS DID NOT OCCUR, BUT WAS THEN DISCHARGED IN STABLE CONDITION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 23360422 ↗
• MalfunctionSep 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR A TKA, THE INTERNAL PACKAGE OF ONE (1) JOURNEY TIBIA BASE NP LT SZ 3 WAS NOTICED DAMAGED AND NON-STERILE BUT EXTERIOR PACKAGE WAS INTACT. A S&N BACKUP DEVICE WAS AVAILABLE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963828 ↗
• InjuryApr 2, 2025Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A GROSS MALROTATION OF ONE (1) JOURNEY TIBIA BASE NP LT SZ 3. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKR SURGERY ON (B)(6) 2025, IN WHICH ALL COMPONENTS WERE REVISED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21753292 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2023, ON (B)(6) 2024 AN ARTHROSCOPIC SYNOVECTOMY WAS PERFORMED TO TREAT A LATERAL IMPINGEMENT DISORDER, ON (B)(6) 2024 A SUBCUTANEOUS MASS FORMATION WAS DETECTED ON THE PROXIMAL LATERAL SIDE OF THE LEFT TIBIA. ALSO, THE PATIENT PRESENTED PAIN, SWELLING, FEVER AND FEELING OF WRONGNESS. ON (B)(6) 2024 A SUBCUTANEOUS MASS PUNCTURE WAS PERFORMED AND STAPHYLOCOCCUS EPIDERMIDIS WAS DETECTED. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO REMOVE THE IMPLANTS AND EXCHANGE THEM FOR A COMPETITOR'S KNEE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Joint Impingement

  MAUDE report 20819369 ↗
• MalfunctionAug 6, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A TKA, A JOURNEY TIBIA BASE NP LT SZ 3 WAS OPENED AND IMPLANTED, EVEN THOUGH IT WAS THE WRONG IMPLANT. THERE WAS A SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924823 ↗
• InjuryJul 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT WAS DIAGNOSED WITH ASEPTIC LOOSENING OF THE JOURNEY TIBIA BASE NP LT SZ 3 COMPONENT ON (B)(6) 2024. THEREFORE, A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2024. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19861965 ↗
• InjuryDec 8, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED LOOSENING OF ONE (1) JOURNEY TIBIA BASE NP LT SZ 3, THIS EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15938827 ↗
• InjuryApr 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14040852 ↗
• InjuryApr 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ASEPTIC LOOSENING IN HER KNEE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE JOURNEY KNEE SYSTEM TO A LEGION SYSTEM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14040663 ↗
• InjuryDec 14, 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 INFECTION, SWELLING AND FEVER FROM PRIMARY SURGERY. THIS ADVERSE EVENT WAS SOLVED BY DOING A REVISION SURGERY TO EXTRACT JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM ((B)(4)), JRNY II BCS FEMORAL OXIN LT SZ 3 ((B)(4)), JOURNEY TIBIA BASE NP LT SZ 3 ((B)(4)) AND GNS II BICONVEX PAT 23MM ((B)(4)) ON (B)(6) 2021 AND IMPLANT COMPETITOR IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fever; Swelling/ Edema; Unspecified Infection

  MAUDE report 13002289 ↗
• InjuryOct 26, 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 HAS HAD UNSPECIFIED SYMPTOMS ASSOCIATED TO COBALT ALLERGY. THE PATIENT ALSO REPORTS THAT 2 MANIPULATION SURGERIES, 6 MONTHS OF PT, AND PAIN BLOCKERS PUT IN POST SURGERY MADE HER LOSE QUAD MUSCLE FOR ALMOST A YEAR. A REVISION SURGERY MIGHT BE REQUIRED TO SOLVE THE REPORTED EVENT; BOTH THE FEMUR AND THE PATELLA CONTAIN TRACE AMOUNTS OF COBALT; THEREFORE, IT IS UNCERTAIN WHICH COMPONENT, IF ANY OR BOTH, IS CAUSING THE REACTION. THE CONDITION OF THE PATIENT IS ONGOING.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Implant Pain; Muscle Weakness/Atrophy

  MAUDE report 12701322 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. THE REPORTED DEVICES WERE A JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3-4 LT 9MM, A JOURNEY TIBIA BASE NP LT SIZE 3 , A GENESIS II 7.5MM RESUR PATELLA 29MM AND A JRNY II BCS FEM COCR LT SZ 4. THE SURGEON STATED THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Unspecified Infection

  MAUDE report 12017200 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: JOURNEY II CR RETRO: IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS ON THE LEFT KNEE, IT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. THE OUTCOME IS RESOLVED. REHABILITATION WAS PRESCRIBED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Fibrosis

  MAUDE report 10365755 ↗
• InjuryJul 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY OF TOTAL KNEE ARTHROPLASTY WAS BEING PERFORM DUE TO THE TIBIAL COMPONENT FAILED.

  Patient problems: Injury

  MAUDE report 10324908 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED STIFFNESS IN LEFT KNEE. EVENT WAS RESOLVED WITH AN UNSPECIFIED SURGERY.

  Patient problems: Injury

  MAUDE report 10084288 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE REQUIRING SUBSEQUENT ARTHROSCOPY.

  Patient problems: Injury

  MAUDE report 9485302 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8868014 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO ARTHROFIBROSIS ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8867900 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8867685 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WHICH WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Fibrosis

  MAUDE report 8834727 ↗
• InjuryJul 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACED TO LEGION PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 8787788 ↗
• InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUFFERED A FALL. AN UNSPECIFIED SURGICAL PROCEDURE WAS PERFORMED DUE TO LEFT KNEE ARTHROFIBROSIS. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 8739718 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED LEFT LOWER EXTREMITY NEURITIS. ADVERSE EVENT TREATED WITH MEDICATION. OUTCOME OF THE EVENT IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8704604 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH MEDICATION AND CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8704599 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8704592 ↗

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