JOURNEY 74025625Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556422632), received between Oct 24, 2019 and Oct 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO WEAR. THE INSERT WAS EXCHANGED. PATIENT PRESENTED VIA XRAY AND PHYSICAL EXAM AS UNSTABLE. THEY WENT IN AND FOUND THAT THE MEDIAL SIDE OF HER POLY WAS WORN. THEY REPLACED IT WITH A 1-2 DISHED 15MM INSERT.

  Patient problems: Injury

  MAUDE report 9235254 ↗

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