JOURNEY 74025761Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556098417), received between Sep 15, 2021 and Nov 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA, WHEN OPENING THE BOX OF ONE (1) JRNY II ISRT XLPE DD LT SZ 5-6 9MM IT WAS NOTICED THAT THE DOUBLE STERILE PACKAGES WERE OPENED IN THE SAME PLACE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076295 ↗
• MalfunctionMay 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN OPENING THE BOX, THE JRNY II ISRT XLPE DD LT SZ 5-6 9MM FELL TO THE FLOOR AND IT WAS FOUND THAT THE DOUBLE STERILE PACKAGES WERE OPEN ABOUT 5CM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989126 ↗
• MalfunctionSep 15, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, THE SECOND INNER STERILE PACKAGING OF A JRNY II ISRT XLPE DD LT SZ 5-6 9MM WAS NOT PROPERLY SEALED WHEN OPENED. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477712 ↗

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