JOURNEY 74025663Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556422373), received between May 9, 2019 and Jan 6, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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.

• InjuryJan 6, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13176689 ↗
• MalfunctionMay 9, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING REVISION SURGERY THE CONSTRUCTED IMPLANTS WOULD NOT FIT PROPERLY IN PATIENT. MORE THAN 30 MINUTES OF DELAY WAS REPORTED AND BACKUP DEVICE WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597363 ↗

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