JOURNEY 71422342Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010627315), received between Feb 18, 2019 and Sep 7, 2022 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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) 2015, PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXPLANT 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: Bone Fracture(s)

  MAUDE report 15375246 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A REGULAR POST OPERATIVE ASSESSMENT OF THE PATIENT WAS PERFORMED. THE PATIENT WAS FOUND WITH SEVERE ARTHRO-SYNOVITIS AND A RADIOGRAPH PICTURE SUGGESTED PROBABLE METALLOSIS AND RADIO OPAQUE DEPOSITS AT THE SYNOVIAL LEVEL. A REVISION SURGERY WAS SCHEDULED FOR URGENT SURGICAL CLEANING AND IMPLANT REMOVAL. ON (B)(6) 2020, THE REVISION SURGERY WAS PERFORMED TO REMOVE BAKER CYST AND THE IMPLANTS, WHICH WERE REPLACED WITH A MONO-COMPARTMENTAL SPACER WITH ANTIBIOTIC-LOADED CEMENT. DURING SURGERY, AN INTRACAPSULAR METALOGIC SYNOVITIS (ALSO NEAR THE BAKER CYST) WAS NOTICED. ALSO, THE FOLLOWING IMPLANT FAILURES WERE REMARQUED: DEGENERATION OF THE POLYETHYLENE INSERT IN THE BACK SIDE; CONSUMPTION OF THE CERAMIC AND METAL COATING BELOW THE DISTAL REGION OF THE PROSTHETIC FEMORAL CONDYLE; AND CONSUMPTION OF THE METAL PART IN THE BACK SIDE OF THE TIBIAL COMPONENT.

  Patient problems: Cyst(s); Failure of Implant; Metal Related Pathology; Synovitis

  MAUDE report 10956383 ↗
• InjuryFeb 18, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A CONVERSION OF PARTIAL KNEE ARTHROPLASTY TO A TOTAL KNEE ARTHROPLASTY WAS PERFORMED DUE TO PAIN AND LOOSENING OF JOINT PROSTHESIS.

  Patient problems: Pain

  MAUDE report 8348496 ↗

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