JOURNEY 74024216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556170915), received between Jun 11, 2018 and Jun 12, 2024 — classified as 3 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (K111711, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOW DATE, DUE TO PATIENT'S NICKEL ALLERGY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 , IN WHICH A JRNY II BCS FEMORAL OXIN RT SZ 6 AND A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM WERE EXPLANTED AND REVISED WITH A LEGION OX FEMUR AND CONVERSION POLY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19520112 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A SEPSIS ON THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9255834 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE KNEE BECAME SEPTIC.

  Patient problems: Injury

  MAUDE report 7589795 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5