JOURNEY 74025682Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556422243), received between Mar 19, 2019 and Apr 26, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ACQUIRED LEFT KNEE INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY IN WHICH THE POLY WAS EXCHANGED ON (B)(6) 2020. THE OUTCOME OF THE PATIENT HAS BEEN RESOLVED.

  Patient problems: Joint Laxity

  MAUDE report 14212021 ↗
• InjuryJul 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT PRESENTING A SWOLLEN KNEE AND BIOPSIES INDICATED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8818603 ↗
• InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER UNDERWENT A TOTAL KNEE ARTHROPLASTY FOR A STUDY, THE PATIENT HAD DELAYED WOUND HEALING AND POSSIBLE INFECTION. REVISION SURGERY AND DRAINAGE WERE PERFORMED WITH A POLY EXCHANGE. THE SUBJECT RECOVERED FROM THE EVENT BUT WAS TERMINATED FROM THE STUDY. THE EXPLANTED DEVICE WAS DESTROYED.

  Patient problems: Unspecified Infection

  MAUDE report 8434663 ↗

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