JOURNEY 74022217Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010554390), received between Aug 14, 2017 and Dec 29, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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.

• InjuryDec 29, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A TKR, IT WAS MISSED THAT THE TIBIAL BASEPLATE WAS NOT A GENESISII TIBIAL BASEPLATE, BUT IT WAS JOURNEY TIBIA BASE NP RT SZ 7. THE ITEM WAS IMPLANTED AND WHEN THE SURGEON ATTEMPTED TO INSERT THE POLYETHYLENE TIBIAL INSERT REALIZED IT WOULD NOT SEAT. ON INSPECTION HE REALIZED THE TIBIAL ERROR AND HAD TO REMOVE IT, ALONG WITH THE CEMENT. THE CORRECT GENESISII TIBIAL BASEPLATE WAS BROUGHT TO THE ROOM AND THE PROCEDURE CONTINUED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919209 ↗
• InjurySep 21, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE REPLACEMENT SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SUBSIDENCE OF THE TIBIAL COMPONENT DUE TO PATIENT DEMOGRAPHICS/TIBIAL FRACTURE. NOT IMPLANT FAILURE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY II BCS FEMORAL OXIN RT SZ 9, ONE (1) JOURNEY TIBIA BASE NP RT SZ 7 AND ONE (1) JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WERE REVISED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 23106103 ↗
• InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY, RIGHT TKR, THE PATIENT SUFFERED FROM DISCOMFORT AND REPETITIVE BLEEDING EPISODES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9820357 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 9484152 ↗
• 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 8868019 ↗
• InjuryMay 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER KNEE REPLACEMENT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8643600 ↗
• MalfunctionDec 19, 2018Misconnection; Misconnection

  IT WAS REPORTED THAT THE POLY WOULD NOT LOCK INTO THE TIBIA. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182378 ↗
• InjurySep 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT'S DECEASE 3 MONTHS AFTER RIGHT TOTAL KNEE REPLACEMENT WAS REPORTED.

  Patient problems: Death

  MAUDE report 7911105 ↗
• InjurySep 9, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A SERIOUS INJURY DURING CLINICAL STUDY IN WHICH THERE WAS INFECTION IN RIGHT KNEE. RIGHT PERI-PROSTHETIC INFECTION WITH I&D X 2 AND POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 7858751 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS IN THE RIGHT KNEE. EVENT TREATMENT INCLUDED SURGERY/PROCEDURE.

  Patient problems: Injury

  MAUDE report 7807100 ↗
• InjuryJul 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT KNEE EFFUSION WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7716878 ↗
• InjuryFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE ASPIRATION WAS PERFORMED DUE TO SWELLING OF RIGHT KNEE.

  Patient problems: Joint Swelling

  MAUDE report 7302366 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO FLEXION CONTRACTURE. IT WAS ALSO REPORTED THE PATIENT HAD FALLEN DOWN STAIRS AND HAD SWELLING AND PAIN.

  Patient problems: Loss of Range of Motion; Pain; Swelling

  MAUDE report 7069958 ↗
• InjuryAug 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION RIGHT KNEE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6793765 ↗
• InjuryAug 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT AWOKE WITH A LARGE SWOLLEN, DEFORMED KNEE WITH DRAINAGE FROM SURGICAL SITE. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH AN EXCHANGE OF THE TIBIAL BASEPLATE AND POLY.

  Patient problems: Hematoma

  MAUDE report 6793058 ↗
• InjuryAug 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE REVISION WAS PERFORMED. THERE IS NO INFORMATION GIVEN WHY REVISION WAS DONE.

  Patient problems: Injury; No Information

  MAUDE report 6791447 ↗

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-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
• 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