JOURNEY 74024923Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556611418), received between Sep 30, 2019 and May 31, 2026 — classified as 2 injuries, 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K111711, 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.

• MalfunctionMay 31, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE INNER PACKING OF ONE (1) JRNY II BCS FEM COCR LT SZ 3 WAS FOUND WITHOUT A SEAL, WHICH IS NOT POSSIBLE TO CONFIRM IF THE PRODUCT HAS MAINTAINED ITS STERILE BARRIER. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25343879 ↗
• InjurySep 30, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND LOOSENING OF THE FEMORAL COMPONENT. FEMORAL COMPONENT, BASEPLATE AND INSERT WERE EXCHANGED.

  Patient problems: Injury

  MAUDE report 9137595 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEGION TOTAL KNEE REVISION WAS PERFORMED APPROXIMATELY 16 MONTHS POST SURGERY DUE PAINFUL KNEE AND JOURNEY II FEMORAL COMPONENT LOOSENING. REMOVAL OF LOOSE JOURNEY II BCS SIZE 3 LEFT FEMORAL COMPONENT, TIBIAL BASE PLATE LEFT SIZE 1 AND JOURNEY II BCS XLPE ARTICULAR INSERT LEFT SIZE 1-2, 10MM. NO MORE INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 9135210 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5