JOURNEY 74027238Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556194935), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL STUDY THAT THE PATIENT HAD BEEN REVISED DUE TO A POPPING SOUND IN THE RIGHT KNEE. INTRAOPERATIVELY THE SURGEON CAME ACROSS A PIECE OF BONE ABOUT THE SIZE OF END OF PINKIE WHICH WAS REMOVED AS WELL AS DID DEBRIDEMENT OF POSTERIOR CAPSULAR SCAR TISSUE WHICH MAY HAVE CONTRIBUTED TO POPPING SOUND. TIBIAL LINER HAS BEEN REPLACED BUT WAS NOTED THAT THE LINER WAS WELL FIXED AND HAD NOT DISLODGED.

  Patient problems: Capsular Contracture; Foreign Body In Patient

  MAUDE report 6456608 ↗

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