JOURNEY 74025654Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556422434), received between Sep 5, 2018 and Jul 31, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A FALL AND TORE QUADRICEPS TENDON. PATIENT WAS TAKEN TO SURGERY FOR REPAIR AND POLYETHYLENE PART WAS ALSO REPLACED DURING SURGERY. TWO WEEKS LATER, PATIENT TORE TENDON FOR A SECOND TIME AFTER BEING NON-COMPLIANT WITH WEARING BRACE AND A SECOND SURGERY WAS PERFORMED TO FIX TEAR. TWO WEEKS LATER, TENDON WAS TORN FOR A THIRD TIME AND IT WAS FIXED IN SURGERY AND A FULL LEG CAST WAS GIVEN.

  Patient problems: Injury

  MAUDE report 8845181 ↗
• InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A QUADRICEP TENDON RUPTURE. ACTION TAKEN: SURGERY/PROCEDURE - REVISION WITH POLY CHANGE, DEBRIDEMENT AND QUAD REPAIR.

  Patient problems: Rupture

  MAUDE report 7845788 ↗

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