JOURNEY 71422253Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010582140), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.

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

• MalfunctionJul 20, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING SET UP FOR AN UKA SURGERY, WHEN OPENING THE SEALED PACKAGE AND SEALED BOX OF THE JOURNEY UNI TIBINRT S3-4LM/RL10MM DEVICE, THE PLASTIC INNER PACKAGING (STERILE COVER) LOOKED AS IF IT WAS NOT SEALED AT ALL. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE BUT IT IS UNKNOWN IF THERE WAS ANY DELAY. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368051 ↗

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