JOURNEY 74025711Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556094464), received between Oct 17, 2023 and Feb 7, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113482, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON AN UNSPECIFIED DATE, A JRNY II ISRT XLPE DD RT SZ 1-2 9MM BROKE ON THE POSTEROMEDIAL CORNER. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, IN ORDER TO EXCHANGE THE LINER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21339934 ↗
• MalfunctionOct 17, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA, IT WAS NOTICED THAT THE STERILE PACKAGING OF ONE (1) JRNY II ISRT XLPE DD RT SZ 1-2 9MM WAS OPENED IN THE SEALED BOX. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954481 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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