JOURNEY 74035242Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556156933), received between Jun 30, 2019 and Jul 31, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2024Break; Fracture; Deformation Due to Compressive Stress; Break; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A TKA SURGERY ONE (1) JOURNEY FEM IMPACT BUMPER RT AND ONE (1) JRNY II BCS ART ISRT TRL SZ 3-4 10MM LT BROKE AFTER IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 19873747 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 3-4 10MM LT BROKE WHILE BEING REMOVED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320947 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT THE INSERT IS DAMAGED AND HAS A SMALL CHIP. NO CASE INVOLVED. FOUND AFTER WASH. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097722 ↗
• InjuryDec 15, 2020Break; Break

  IT WAS REPORTED THAT, THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 3-4 10MM LT BROKE DURING A TKA PROCEDURE. ALL PIECES WERE REMOVED BY HAND. IT WAS COMPLETED WITHOUT DELAY WITH SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008020 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH GOUGES/CRACKS/SCRATCHES. NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10322082 ↗
• MalfunctionJun 30, 2019Break; Break

  IT WAS REPORTED THAT PLASTIC TRIAL SPLIT DURING TRIAL PROCESS. NO PROCEDURAL DELAYS. NO HARM TO PATIENT OR STAFF. SMITH AND NEPHEW BACK UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746848 ↗

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