JOURNEY 71422357Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010627438), received between May 31, 2019 and Sep 8, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Connection Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 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) 2017 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A PROGRESSION OF THE DISEASE AND INSTABILITY. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 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: Arthritis; Joint Laxity

  MAUDE report 15385676 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF A JOURNEY UNI KNEE TIBIAL INSERT WAS PERFORMED. PRIMARY IMPLANTATION WAS PERFORMED ON (B)(6) 2016. DURING THE REVISION WAS IDENTIFIED THAT THERE WAS AN UNUSUAL EARLY COMPLETE WEAR OF THE INSERT, ALSO THERE WAS MASSIVE METALLOSIS AND PRONOUNCED SOFT TISSUE DAMAGE. TIBIAL BASEPLATE AND FEMORAL COMPONENT WERE ALSO EXPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Erosion; Failure of Implant; Inadequate Osseointegration; Metal Related Pathology; Unspecified Tissue Injury

  MAUDE report 12080467 ↗
• InjuryApr 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, AFTER A NAVIO ASSISTED UNICONDYLAR KNEE REPLACEMENT, THE PATIENT COLLAPSED INTO VALGUS. IMPLANTS WERE REVISED TO A LEGION HINGE WITH CONES AND STEMS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11720856 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A KNEE REPLACEMENT ON (B)(6) 2018, WHERE HE HAD A BARING LOCKING MECHANISM FITTED. SHORTLY AFTER THE SURGERY THE BARING LOCKING MECHANISM FAILED CAUSING THE CLAIMANT TO SUFFER FROM SEVERE PAIN. THIS REQUIRED THE PATIENT TO UNDERGO A SECOND SURGERY ON (B)(6) 2018 WHICH FAILED AGAIN, AND A THIRD OPERATION WAS REQUIRED ON (B)(6) 2018. THE INSERT, TIBIAL AND FEMORAL COMPONENTS WERE REMOVED AND COMPETITOR DEVICES WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 8660277 ↗

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