JOURNEY 71422245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010582089), received between Mar 8, 2023 and Jul 3, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJul 3, 2023Material Fragmentation; Biocompatibility; Material Fragmentation; Biocompatibility

  IT WAS REPORTED THAT, AFTER A UKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED FEELING OF WRONGNESS. CONSEQUENTLY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN RESPONSE TO THIS ADVERSE EVENT, DURING WHICH METALLOSIS WAS OBSERVED AS A RESULT OF ABNORMAL WEAR OF THE JUNI OX FB FEM SZ 2 RM LL, SO IT WAS EXCHANGED FOR COMPETITOR DEVICE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Metal Related Pathology

  MAUDE report 17249381 ↗
• MalfunctionMar 8, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN UNICONDYLAR KNEE REPLACEMENT SURGERY, A JOURNEY UNI TIBINRT S1-2RM/LL8MM COULD NOT BE IMPLANTED SUCCESSFULLY, AFTER STRIKING IT, IT WAS STILL LOOSE AND COULD NOT BE FIXED. AFTER SEVERAL ATTEMPTS TO FIXATE THE IMPLANT, IT WAS DECIDED TO USE A 1MM LARGER INSERT AND FIXATE IT WITH MULTIPLE TAPPING, BECAUSE THERE WAS NO JOURNEY UNI TIBINRT S1-2RM/LL8MM BACK UP. THIS PROBLEM CAUSED A SIGNIFICANT DELAY. PATIENT CURRENT HEALTH STATUS IS GOOD, NO HARM TO THE PATIENT WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505623 ↗

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