JOURNEY 74027224Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556177365), received between Oct 21, 2019 and Aug 29, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

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.

• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED SWELLING AND INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 1-2 LT 12MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15316042 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE PATIENT HAD ITB SYNDROME. THE DOCTOR CONSIDER THAT ITB SYNDROME AND PAIN WERE NOT CAUSED BY THE PRODUCT. THE PATIENT HAD ORIGINALLY KNEE VALGUS.

  Patient problems: Injury

  MAUDE report 9714938 ↗
• InjuryOct 21, 2019Unstable; Unstable

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE PATIENT EXHIBITED DECREASED RANGE OF MOTION IN LEFT KNEE WITH INSTABILITY. A REVISION SURGERY WAS PERFORMED TO EXCHANGE POLYETHYLENE AND TIBIAL COMPONENT.

  Patient problems: Injury

  MAUDE report 9216078 ↗

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-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; 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