JOURNEY 74025744Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556097762), received between Dec 24, 2020 and May 17, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113482, 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.

• InjuryMay 17, 2024Deformation Due to Compressive Stress; Migration; Deformation Due to Compressive Stress; Migration

  IT WAS REPORTED THAT AFTER A TKA SURGERY, THE PATIENT EXPERIENCED A JRNY II ISRT XLPE DD LT SZ 3-4 12MM TRANSLATED FORWARD AROUND 1CM AND WAS LONGER LOCKED INTO THE BASEPLATE. THIS ADVERSE EVENT WAS TREATED BY PUTTING ONE DISHED 3-4 X 13MM INSERT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19343269 ↗
• InjuryDec 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11072337 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113482, 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