JOURNEY 71934546Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556183168), received between Aug 22, 2018 and Aug 22, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110837, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN AND SWELLING. SURGERY SCHEDULED TO IDENTIFY ISSUE AND IT WAS NOTICED THE INSERT WAS NOT COMPLETELY LOCKED INTO TIBIA BASE. REMOVED INSERT AND REPLACED WITH JII CONSTRAINED INSERT.

  Patient problems: Pain; Swelling

  MAUDE report 7805309 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110837, 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