JOURNEY 71422343Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010627322), received between Aug 1, 2019 and Sep 5, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2019 WERE ALL COMPONENTS WHERE EXCHANGE. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15354141 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TKA HAVE BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED ON (B)(6) 2021 LATERAL COMPARTMENT OSTEOPHYTES (FEMORAL AND TIBIAL) OF LEFT KNEE. THE INVOLVED DEVICES ARE: JUNI OX FB FEM SZ 3 LM RL, JII UNI TIB BASE SZ 1 LM/RL AND THE JII UNI TIB XLPE INS SZ 1-2 9MM LM/RL; HOWEVER, IT IS UNKNOWN HOW THEY FAILED. NO ACTIONS HAVE BEEN TAKEN. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Extraskeletal ossification

  MAUDE report 11978534 ↗
• InjuryAug 1, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED DUE TO TIBIAL FRACTURE AND BASEPLATE LOOSENING. ALL IMPLANTS WERE EXCHANGED TO LEGION.

  Patient problems: Injury

  MAUDE report 8850942 ↗

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