JOURNEY 74035232Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556207543), received between Oct 8, 2020 and Apr 23, 2025 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionApr 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 3-4 10MM RIGHT BROKE IN HALF. ALL PIECES WERE ACCOUNTED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893630 ↗
• MalfunctionOct 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA, THE TECH ACCIDENTALLY HANDED SURGEON ONE (1) JRNY II BCS ART ISRT TRL SZ3-4 10MM RT TO TRIAL ON A SIZE 2 BASEPLATE. WAS NOT NOTICED AND SURGEON ATTEMPTED TO SEAT THE TRIAL, DAMAGING THE BOTTOM OF PLASTIC. ALL PIECES WERE REMOVED FROM PATIENT USING PICKUPS. 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 20487888 ↗
• 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 20131374 ↗
• MalfunctionDec 21, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICE WAS FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047780 ↗
• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE JRNY II BCS ART ISRT TRL SZ3-4 10MM RT CRACKED OFF. THIS HAPPENED DURING USE INSIDE THE PATIENT. NO DELAY. S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10652306 ↗

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