JOURNEY 74034233Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556002896), received between Apr 14, 2019 and Apr 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K140555); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE IN HALF DURING SURGERY. NO DELAY OR INJURY REPORTED. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512767 ↗
• MalfunctionApr 14, 2019Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE THE INSERT TRIAL CRACKED AND BROKE IN HALF. ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512678 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555. 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