JOURNEY 74025672Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556422311), received between Jul 24, 2018 and Jun 5, 2022 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionJun 5, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE INNER PACKAGE OF A JRNY II CR ISRT XLPE RT SZ 7-8 10MM WAS FOUND TO BE NOT SEALED, COMPROMISING THE STERILITY OF THE IMPLANT. AS A SMITH AND NEPHEW BACKUP INSERT WAS AVAILABLE WHEN THIS ISSUE WAS NOTICED, THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED AND THE SURGEON WAS SATISFIED WITH THE OUTCOME OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599747 ↗
• InjuryJul 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A RIGHT KNEE EFFUSION.

  Patient problems: Injury

  MAUDE report 7715921 ↗

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