JOURNEY 71422352Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010627384), received between Dec 12, 2022 and Jan 13, 2023 — classified as 2 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 (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT REQUIRED A CONVERSION TO TKA ON AN UNKNOWN DATE DUE TO UNSPECIFIED COMPLICATIONS AND/OR ADVERSE EVENTS. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED FORTY FOUR (44) MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16163541 ↗
• InjuryDec 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN UNSPECIFIED COMPLICATION THAT MADE NECESSARY A REVISION SURGERY WITH A CONVERSION TO A TKA. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED FORTY FOUR (44) MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15964504 ↗

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