JOURNEY 74035233Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556157534), received between Dec 30, 2020 and Sep 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 3-4 11MM RT BROKE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE BECAUSE THE PART WAS NOT NEEDED ANY LONGER. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939106 ↗
• MalfunctionSep 3, 2024Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ3-4 10MM RT AND ONE (1) JRNY II BCS ART ISRT TRL SZ 3-4 11MM RT WERE SCRATCHED AND HAD FLAKING PIECES OF PLASTIC. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131378 ↗
• MalfunctionNov 8, 2021Crack; Crack

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 3-4 11MM RT IS CRACKED. AS THIS WAS NOTICED UPON AN INSPECTION, THERE WAS NOT ANY PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770940 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT A JRNY II BCS ART ISRT TRL SZ 3-4 11MM RT IS BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577284 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT AFTER TKA PROCEDURE, WAS FOUND THAT A PIECE OF PLASTIC CHIPPED OFF FROM THE JOURNEY II BCS ART INSERT TRIAL SIZE 3-4 11MM RIGHT. NO ADDITIONAL COMPLICATIONS WERE REPORTED. 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 11097787 ↗

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