JOURNEY 71422263Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010582225), received between Dec 12, 2018 and Aug 7, 2020 — 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 (K061011, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 7, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A SURGERY, THE JOURNEY UNI TIBINRT S5-6LM/RL10MM INSERT DID NOT BECOME FIXED INTO THE TIBIAL COMPONENT. IT IS UNKNOWN HOW THE PROCEDURE CONCLUDED, IF THERE WAS A DELAY OR AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10382831 ↗
• InjuryDec 12, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFENING IN THE PATIENT'S LEFT KNEE RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8155924 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061011, 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