JOURNEY 74035244Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556207246), received between Jun 25, 2020 and Apr 13, 2023 — classified as 3 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K111711); 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.

• MalfunctionApr 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE BOTTOM OF THE JRNY II BCS ART ISRT TRL SZ3-4 12MM LT CHIPPED WHILE TRIALING. THE PROCEDURE HAD BEEN COMPLETED, WITH A S+N BACK-UP DEVICE. IT IS UNKNOWN IF A DELAY WAS PRESENTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735605 ↗
• MalfunctionOct 26, 2021Break; Break

  IT WAS REPORTED THAT A JOURNEY II BCS ART INSERT TRIAL SIZE 3-4 12 MM LEFT IS CHIPPED AND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697916 ↗
• MalfunctionJun 25, 2020Crack; Crack

  IT WAS REPORTED THE DEFECTIVE DEVICE WAS FOUND DURING WAREHOUSE INSPECTION. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10194385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711. 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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5