JOURNEY 71461011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010573315), received between Sep 13, 2017 and Mar 18, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K051086, K093056, 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 16, 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.

• InjuryMar 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO DISEASE PROGRESSION, NOT IMPLANT FAILURE. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 8429570 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN IMPLANT.

  Patient problems: Injury

  MAUDE report 8326056 ↗
• InjurySep 13, 2017Adverse 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 A RIGHT KNEE JOURNEY PFJ WAS REVISED TO A TKA DUE TO PROGRESSION OF DISEASE. THE PATELLA WAS INSPECTED AND LEFT IN SITU.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6863319 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051086, K093056, 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