JOURNEY 74025652Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556422458), received between May 23, 2017 and Jun 1, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE A TKR, IT WAS NOTICED THAT, THE EXTERNAL BOX OF ONE (1) JRNY II CR ISRT XLPE RT SZ 5-6 10MM WAS INTACT EXTERNALLY AND WAS VISUALLY CHECKED BY SCRUB STAFF (CELLOPHANE, BOX), BUT ONCE THEY OPENED THE INTERNAL PACKAGING (2 LAYERS), OPEN AND STERILE IMPLANT WAS LOOSE IN THE BOX. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354715 ↗
• InjuryMar 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [ STUDY: JOURNEY II CR RETRO; SUBJECT ID: NYU-0142 (198320142); AE#: 2 ]. IT WAS REPORTED THAT, AFTER A JOURNEY II CR SYSTEM HAD BEEN IMPLANTED, THE CLINICAL SUBJECT EXPERIENCED DVT IN LEFT LEG. THIS ADVERSE EVENTS WAS RESOLVED WITH MEDICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11580451 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A CLOSED MEDICAL MANIPULATION UNDER ANESTHESIA, DUE TO ARTHROFIBROSIS IN THE RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8712734 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED RIGHT KNEE ARTHROFIBROSIS. A MANIPULATION UNDER ANESTHESIA WAS DONE.

  Patient problems: Injury

  MAUDE report 7470884 ↗
• InjuryMay 23, 2017Unstable; Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED WITH EXCHANGE OF A TIBIAL INSERT TO A THICKER DISHED ONE AS THE PATIENT WAS UNSTABLE IN THE KNEE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6583861 ↗
• InjuryMay 23, 2017Loss of or Failure to Bond; Unstable; Loss of or Failure to Bond

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED WITH EXCHANGE OF A TIBIAL INSERT TO A THICKER DISHED ONE AS THE PATIENT WAS UNSTABLE IN THE KNEE.

  Patient problems: Injury; No Code Available

  MAUDE report 6583794 ↗

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