JOURNEY 71422266Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010582256), received between Oct 16, 2018 and Feb 14, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY UKA PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO SOLVE THE ISSUE. THE WOUND WAS WASHED AND DEBRIDED THOROUGHLY. THE INSERT DID NOT HAVE ANY VISIBLE DEFECTS, BUT IT WAS EXPLANTED AND REPLACED FOR ANOTHER S+N INSERT OF THE SAME SIZE. THE PATIENT CURRENT HEALTH STATUS IS CURRENTLY UNKNOWN.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 18707233 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6)2020 TO ADDRESS A MEDIAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6)2020 DUE TO A WOUND HEALING DISORDER WHERE THE TIBIAL INSERT WAS EXCHANGED. THE OUTCOME OF THIS PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED RETROSPECTIVELY; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16542730 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 5 MONTHS AFTER KNEE REPLACEMENT, A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 8362175 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE UNI IMPLANTS FAILED AS PER SURGEON DR. (B)(6). REVISION SURGERY PERFORMED TO EXPLANT DEVICES. UNABLE TO SEE LOTS DUE TO BONE INGROWTH.

  Patient problems: Injury

  MAUDE report 7970321 ↗

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