JOURNEY 74025623Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556422656), received between May 23, 2017 and Nov 3, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, IN A CLINICAL STUDY, AFTER A LEFT TKA WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A MEDIAL AND LATERAL LEFT KNEE PAIN AND INSTABILITY FOLLOWING TRAUMA TO ANTERIOR KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, IN WHICH THE JRNY II CR ISRT XLPE LT SZ 1-2 11MM WAS EXPLANTED AND WAS NOTICED BROKEN IN THE POSTEROMEDIAL SIDE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Crepitus; Implant Pain; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 23450985 ↗
• InjuryMay 23, 2017Unstable

  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: No Code Available

  MAUDE report 6583846 ↗

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