JOURNEY 71422344Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010627339), received between Dec 27, 2019 and Nov 3, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2019 IN WHICH A JUNI OX FB FEM SZ 4 LM RL, A JII UNI TIB BASE SZ 6 LM/RL AND A JII UNI TIB XLPE INS SZ 5-6 9MM LM/RL WERE IMPLANTED, THE PATIENT PRESENTED CELLULITIS ON THEIR LEFT KNEE. THIS WAS TREATED WITH MEDICINE AND WAS REPORTEDLY RESOLVED. NO FURTHER DETAILS AT THIS TIME.

  Patient problems: Cellulitis

  MAUDE report 23452626 ↗
• InjurySep 8, 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) 2017 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. A REVISION SURGERY WAS PERFORMED TO ADDRESSED THIS ISSUE ON (B)(6) 2018 AND ALL IMPLANTS WERE EXCHANGED. 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 15385497 ↗
• InjurySep 8, 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) 2013 DUE TO OSTEOARTHRITIS, THE PATIENT PRESENTED INFECTION. A REVISION SURGERY WAS PERFORMED TO ADDRESSED THIS ISSUE ON (B)(6) 2018 AND ALL IMPLANTS WERE EXCHANGED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), 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: Unspecified Infection

  MAUDE report 15385193 ↗
• InjurySep 7, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT UKA SURGERY PERFORMED IN (B)(6) 2014, PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS, ALSO PROGRESSIVE ARTHRITIS. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017 TO EXCHANGE THE TIBIAL COMPONENT AND 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: Inadequate Osseointegration

  MAUDE report 15375398 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT UKA SURGERY PERFORMED IN (B)(6) 2016, PATIENT EXPERIENCED AN INFECTION. THIS EVENT WAS ADDRESSED BY CONDUCTING AN ADDITIONAL SURGERY ON (B)(6) 2017, BUT IT IS UNKNOWN WHAT SPECIFIC INTERVENTION WAS PERFORMED. THE COMPONENTS WERE NOT EXPLANTED. 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: Unspecified Infection

  MAUDE report 15363297 ↗
• InjurySep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A IMPLANT FRACTURE AND AN UNSPECIFIED OTHER ISSUE. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 WERE ALL COMPONENTS WHERE EXCHANGE. THIS INFORMATION WAS PROVIDED BY THE (B)(6), 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: Failure of Implant; Insufficient Information

  MAUDE report 15360246 ↗
• InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) JULY 2019 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) JUNE 2021 WERE ALL COMPONENTS WHERE EXCHANGE. 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 15354166 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A UKR, WHILST IMPLANTING THE FEMUR THE SURGEON NOTICED FEMORAL COMPONENT WAS SITTING TOO FLEXED. UNSURE OF HOW THIS OCCURRED, POSSIBLY DUE TO THE CUTS MADE THROUGH THE 2:1 CUTTING BLOCK. THIS WAS CAUSING AN IMPINGEMENT ON THE PATELLA. SURGEON DOWN SIZED AND USED A SIZE 3 UNI-COMPONENT INSTEAD.

  Patient problems: Injury

  MAUDE report 9527654 ↗

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