JOURNEY 71422363Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010627469), received between Dec 19, 2018 and Mar 15, 2023 — classified as 3 injuries.

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 (K073175, K081351, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2019 TO ADDRESS A LATERAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A CONVERSION TO TKA ON (B)(6) 2019 DUE TO AN UNSPECIFIED INFECTION. 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: Unspecified Infection

  MAUDE report 16542719 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A MEDIAL UKA SURGERY, HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PATELLOFEMORAL JOINT PAIN IN THE LEFT KNEE. THE PATIENT'S OUTCOME HAS NOT BEEN RESOLVED, AND A HYALURONIC ACID INJECTION HAS BEEN SCHEDULED. FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Arthralgia

  MAUDE report 14331928 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A SLOW POST-OPERATIVE RECOVERY DUE TO PAIN, SO THE HOSPITALIZATION WAS PROLONGED.

  Patient problems: Injury

  MAUDE report 8177596 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073175, K081351, 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