JOURNEY 71422354Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010627407), received between Oct 29, 2019 and Sep 7, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 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) 2014, PATIENT EXPERIENCED UNEXPLAINED PAIN. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXPLANT THE FEMORAL AND TIBIAL COMPONENTS. 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: Pain

  MAUDE report 15375223 ↗
• InjurySep 7, 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) 2013, THE PATIENT EXPERIENCED UNEXPLAINED PAIN. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2015 TO EXPLANT THE FEMORAL AND TIBIAL COMPONENTS. 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: Pain

  MAUDE report 15375167 ↗
• InjurySep 7, 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) 2014, PATIENT EXPERIENCED INSTABILITY. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXCHANGE THE FEMORAL AND TIBIAL COMPONENTS, AND INSERT. 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: Joint Laxity

  MAUDE report 15375164 ↗
• 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 ON (B)(6) 2016, PATIENT EXPERIENCED INSTABILITY. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017 TO EXCHANGE THE FEMORAL AND TIBIAL COMPONENTS AND THE INSERT. 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: Joint Laxity

  MAUDE report 15363741 ↗
• 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 TKA PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN UNSPECIFIED ISSUE. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 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: Insufficient Information

  MAUDE report 15360324 ↗
• InjurySep 5, 2022Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2016 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 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: Inadequate Osseointegration

  MAUDE report 15358432 ↗
• InjurySep 4, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED INSTABILITY, STIFFNESS AND A PROGRESSION OF THE ARTHRITIS. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2018 AND ALL COMPONENTS WERE EXPLANTED WITHOUT DETAILS OF WHICH COMPONENT FAILED (IF ANY). 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: Arthritis; Joint Laxity; Muscular Rigidity

  MAUDE report 15354101 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE CAUSE OF THE REVISION SURGERY IS UNSPECIFIED. THE PATIENT HAS RECOVERED FROM REVISION SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12924289 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UKA SURGERY HAD BEEN PERFORMED WITH A JOURNEY UNI SYSTEM ON AN UNSPECIFIED DATE, LEFT KNEE PAIN WORSENED FOR THE CLINICAL SUBJECT DUE TO PROGRESSION OF OSTEOARTHRITIS. CLINICAL SUBJECT HAS NOT BEEN TREATED YET, BUT A CONVERSION TO TKA IS PLANNED.

  Patient problems: Pain

  MAUDE report 12155210 ↗
• InjuryOct 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF THE TIBIAL COMPONENT. ALL PARTS WERE REMOVED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9251568 ↗

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