JOURNEY 71422345Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010627346), received between Jul 26, 2018 and Aug 14, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K073175, K081351, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025 IN WHICH ONE (1) JOURNEY UNI TIBINRT S3-4LM/RL8MM, ONE (1) JRNY UNI TIBIAL BASE LM/RL SZ 4 AND ONE (1) JUNI OX FB FEM SZ 5 LM RL WERE EXCHANGED USING TKA IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 22802094 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A LEFT UKA SURGERY PERFORMED IN (B)(6) 2017, THE PATIENT EXPERIENCED AN UNSPECIFIED FRACTURE. IT IS UNKNOWN HOW THIS WAS RESOLVED OR IF THIS CAUSED ANY DELAY. THE FEMORAL, TIBIAL AND THE INSERT COMPONENTS WERE IMPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO EXPERIENCED AN ADVERSE EVENT DURING A UKA WHERE JOURNEY UNI IMPLANTS WERE IMPLANTED. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15375389 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT UKA SURGERY PERFORMED IN (B)(6) 2016, PATIENT EXPERIENCED UNEXPLAINED PAIN, STIFFNESS AND OTHER UNSPECIFIED COMPLICATION. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017 TO EXCHANGE THE FEMORAL AND TIBIAL COMPONENTS, THE INSERT AND IMPLANT A PATELLAR COMPONENT. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 15363816 ↗
• InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2016 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 WERE ALL COMPONENTS WHERE EXCHANGE TO COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15358765 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2016 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED PROGRESSION OF THE DISEASE AND UNEXPLAINED PAIN. A REVISION SURGERY TO ADDRESSED THIS ISSUE ON (B)(6) 2018 AND ALL IMPLANTS WERE EXCHANGED FOR COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Arthritis; Pain

  MAUDE report 15358752 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE TIBIAL BASEPLATE BECAME LOSE, THE CEMENT WAS STILL ATTACHED TO THE TIBIAL IMPLANT BUT CEMENT FAILED (LOOSENED FROM TIBIAL BONE), IT WAS NOT A S&N CEMENT. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2021, IN WHICH THE ORIGINAL UNI IMPLANTS WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12908637 ↗
• InjuryJul 26, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY ON LEFT KNEE WAS PERFORMED DUE TO PAIN AND SWELLING. PATIENT WAS TREATED WITH A JOINT INJECTION ON (B)(6) 2018. SINCE THE ISSUE WASN'T RESOLVED WITH THE INJECTION, DR DECIDED TO PERFORM A SURGICAL PROCEDURE ON (B)(6) 2018 TO REMOVE THE PARTS.

  Patient problems: Joint Swelling; Pain

  MAUDE report 7724620 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073175, K081351, 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