JOURNEY 74021255Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556615171), received between Jul 26, 2019 and Feb 21, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2022Migration; Migration

  IT WAS REPORTED THAT, AFTER A RIGHT TKA PERFORMED ON (B)(6) 2020, DUE TO EXTENSIVE VALGUS, SYNOVITIS, AND GONARTHROSIS IN THE RIGHT RETROPATELLAR, THE PATIENT EXPERIENCED PATELLAR PAIN ON MOTION ACCENTUATED LATERALLY WITH A STICKY CRUNCH AND SYNOVITIS. ALSO, THE PATELLAR COMPONENT WAS NOT LOCATED IN THE FEMORAL NOTCH. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 TO REPLACE KNEE COMPONENTS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Discomfort; Joint Dislocation; Pain

  MAUDE report 13573241 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8868037 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WITH DECREASED RANGE OF MOTION AND KNEE PAIN. MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2018 TO RESOLVE THIS ISSUE.

  Patient problems: Injury

  MAUDE report 8830828 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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