JOURNEY 74035223Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556207192), received between Feb 24, 2021 and Apr 20, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A PLASTIC PIECE FROM THE BOTTOM OF THE JRNY II BCS ART ISRT TRL SZ1-2 11MM LT BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781977 ↗
• MalfunctionMar 4, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ1-2 11MM LT WAS FOUND CRACKED AND SCRATCHED. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666596 ↗
• MalfunctionDec 28, 2021Crack; Crack

  IT WAS REPORTED THAT A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11MM LEFT IS CRACKED/CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13093233 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861535 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND/OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861116 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT THE PLASTIC OF A JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 11MM LEFT IS BROKEN OFF AT TIBIA BASEPLATE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755159 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488060 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA, THE JRNY II BCS ART ISRT TRL SZ1-2 11MM LT BROKE WHILE IN USE, EXTERNAL TO THE PATIENT. NO PIECES FELT INSIDE OF THE PATIENT. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849740 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA THE JOURNEY II BCS ART INSERT TRIAL SIZE 1-2 11MM LEFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WAS NO INJURIES NOR DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11374868 ↗

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