JOURNEY 71422252Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010582133), received between Sep 25, 2018 and Jan 8, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING UKA SURGERY, A JOURNEY UNI TIBINRT S3-4LM/RL9MM COULDN'T LOCK TIGHTLY. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465603 ↗
• InjuryDec 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAD A BREAKAGE OF THE KNEE IMPLANT. UNKNOWN IF A REVISION SURGERY WAS PERFORMED ALREADY.

  Patient problems: Injury

  MAUDE report 9434003 ↗
• InjuryDec 2, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF THE KNEE JOINT.

  Patient problems: Injury

  MAUDE report 9394681 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A CONVERSION OF PARTIAL KNEE ARTHROPLASTY TO A TOTAL KNEE ARTHROPLASTY WAS PERFORMED DUE TO PAIN AND LOOSENING OF JOINT PROSTHESIS.

  Patient problems: Pain

  MAUDE report 8359258 ↗
• MalfunctionSep 25, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING UNICONDYLAR KNEE ARTHROPLASTY DUE TO ANTEROMEDIAL GONARTHROSIS, 9 MM INSERT WAS TRIED TO BE USED BUT IT COULDNT BE PLACED ALTHOUGH IT WAS MEASURED DURING TRIAL. AFTER MAKING 1 HOUR EFFORT 8 MM INSERT WAS USED WITHOUT ANY PROBLEM.

  Patient problems: No Information

  MAUDE report 7908165 ↗

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