JOURNEY 74035282Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556157381), received between Jun 8, 2020 and Mar 18, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 7-8 10MM LT SNAPPED DURING RANGE OF MOTION ONCE SET IN KNEE. 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 18926942 ↗
• MalfunctionDec 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 7-8 10MM LT BROKE WHILE TRIALING. IT DID NOT WORK INSIDE PATIENT. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409154 ↗
• MalfunctionApr 7, 2022Crack; Crack

  IT WAS REPORTED THAT THE ANTERIOR ASPECT OF THE JRNY II BCS ART ISRT TRL SZ 7-8 10MM LT CRACKED/SCRATCHED. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048249 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 7-8 10MM LEFT WAS NOTICED TO BE BROKEN. THE DEVICE BROKE IN AUTOCLAVE. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548610 ↗
• MalfunctionFeb 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE INSERT TRIAL BROKE, INSTRUMENTS OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO DELAY OR FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294642 ↗
• MalfunctionJun 8, 2020Break; Break

  IT WAS REPORTED THAT DURING USE OUTSIDE THE PATIENT THE TRIAL CHIPPED. TRIAL WAS HIT WITH A MALLET. NO DELAY REPORTED, IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10127899 ↗

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-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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5