JOURNEY 74027215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556178867), received between Nov 30, 2017 and May 12, 2023 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2023Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT, DURING AN TKA SURGERY, ONE (1)JRNY II BCS XLPE ART ISRT SZ 1-2 RT 13MM COULD NOT BE FULLY SEATED INTO THE BASEPLATE; AND THE PART THAT HOOKED UP THE INSERTER CHIPPED OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924589 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. INSERT WAS REPLACED TO NEW ONE AND OTHER PRODUCTS WERE REMAINED. THE DOCTOR DOESN'T BLAME PRODUCT. NO X-RAYS OR SURGICAL INFORMATION AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8348858 ↗
• InjuryJun 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE BECAUSE IT TAKES LONG TIME AFTER IMPLANTATION. THE PRODUCTS CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7564068 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT RECEIVED KENALOG INJECTION/MEDROX DUE TO PES ANSERINUS TENDONITIS/ BURSITIS RIGHT KNEE.

  Patient problems: Inflammation

  MAUDE report 7072545 ↗

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