JOURNEY 74022215Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010554291), received between Nov 27, 2017 and Feb 18, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A JOURNEY TIBIA BASE NP RT SZ 5 WAS OPENED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392675 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021. AN UNSPECIFIED JOURNEY IMPLANT WAS REPLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13210137 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A DECREASED ROM ON THE RIGHT KNEE. A REVISION SURGERY WITH S+N TIBIAL INSERT WAS PERFORMED TO RESOLVE THE ADVERSE EVENT.

  Patient problems: Injury

  MAUDE report 10720272 ↗
• InjuryMar 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE A BROKEN POLY.

  Patient problems: Injury

  MAUDE report 9857331 ↗
• InjuryOct 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING.

  Patient problems: Injury

  MAUDE report 9235240 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND THIS CAUSED A RUPTURED PATELLAR TENDON, THIS WAS SURGICALLY CORRECTED.

  Patient problems: Injury

  MAUDE report 8867741 ↗
• InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH HEPARIN DUE TO DEEP VEIN THROMBOSIS.

  Patient problems: Injury

  MAUDE report 8796503 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED BILATERAL PULMONARY EMBOLISM AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH HOSPITALIZATION AND MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAD TO RECEIVE REMEDIAL THERAPY TO RESOLVE THE ADVERSE EVENT.

  Patient problems: Pulmonary Embolism

  MAUDE report 8600427 ↗
• InjuryMay 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LIMITED RANGE OF MOTION AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH MANIPULATION UNDER ANESTHESIA WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8584922 ↗
• InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ARTHROFIBROSIS RIGHT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED FOR WHICH SUBJECT WAS HOSPITALISED.

  Patient problems: Injury

  MAUDE report 8536322 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A A TKA PROCEDURE, PATIENT EXPERIENCED PAIN IN HIS RIGHT KNEE. NO SIGNS OF NEUROPATHIC PAIN. KNEE WAS WARM AND SWOLLEN. PATIENT REQUIRED HOSPITALIZATION. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Pain

  MAUDE report 8479203 ↗
• InjuryJan 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED AN IT BAND SYNDROME AND RIGHT PATELLA FEMORAL CLUNK CREPITATION FOR WHICH A KNEE ARTHROSCOPY WAS PERFORMED. NO REVISION REQUIRED. NO ADDITIONAL INFORMATION SPECIFIED.

  Patient problems: Injury

  MAUDE report 8260743 ↗
• InjuryNov 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSERT DISASSOCIATION FROM BASEPLATE. DURING REVISION SURGERY, THE SURGEON FOUND THAT BONE CEMENT INTERVENED BETWEEN BASEPLATE AND INSERT.

  Patient problems: Injury

  MAUDE report 8100388 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION THERE WAS A SURGERY COMPLICATION, PATIENT HAD A PULMONARY EMBOLISM/ DVT.

  Patient problems: Pulmonary Embolism; Thrombosis

  MAUDE report 8051060 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISED WAS PERFORMED DUE TO STIFFNESS AFTER A RIGHT TKA.

  Patient problems: Injury

  MAUDE report 7075088 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFILTRATION WITH DEPO-MEDROL WAS PERFORMED DUE TO HYDROPS.

  Patient problems: Injury; Joint Swelling; Pain

  MAUDE report 7060308 ↗

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-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-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-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