JOURNEY 74021152Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556531884), received between Apr 3, 2019 and Aug 14, 2025 — 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 (K121443, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A PRIMARY TKA SURGERY, HAD BEEN PERFORMED ON (B)(6) 2024, AND A FIRST REVISION SURGERY ON (B)(6) 2024 (B)(5), THE PATIENT EXPERIENCED LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY (B)(6) 2025 IN WHICH THE JRNY II CR FEM OX NP RT SZ 2, THE JOURNEY TIBIA BASE NP RT SZ 2 AND THE JII MD XLPE ART ISRT SZ 1-2 RT 12MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 22811739 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A PRIMARY TKA SURGERY PERFORMED ON (B)(6) 2023 AND A FIRST REVISION SURGERY ON (B)(6) 2024 (REFERENCE: 1020279-2024-00479), THE PATIENT WAS SCHEDULED FOR A SECOND REVISION SURGERY DUE TO AN UNSPECIFIED REASON. THE PROCEDURE WAS PLANNED FOR ON (B)(6) 2025 AND INVOLVED THE REMOVAL OF ALL IMPLANTS, INCLUDING A JRNY II ISRT XLPE DD RT SZ 1-2 11MM, GEN II 7.5MM RESUR PAT 29MM, JRNY II CR FEM OX NP RT SZ 2, AND JOURNEY TIBIA BASE NP RT SZ 2. AT THIS TIME, NO FURTHER DETAILS REGARDING THE SCHEDULED SURGERY OR THE PATIENT'S CURRENT HEALTH STATUS ARE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22561359 ↗
• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEBRIDEMENT SURGERY DUE TO WOUND DEHISCENCE OF DISTAL RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8892461 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAIN. THE XR INSERTS WERE REPLACED.

  Patient problems: Pain

  MAUDE report 8480369 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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