JOURNEY 74035273Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556157886), received between Nov 3, 2020 and Apr 5, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JRNY II BCS ART ISRT TRL SZ 7-8 11MM RT BROKE IN HALF. ALL PIECES WERE RETRIEVED FROM THE PATIENT WITH A QUARTER INCH OSTEOTOME. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013714 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED THAT DURING EFIP INSPECTION PROCESS WAS FOUND THAT THE BOTTOM OF THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 11MM RIGHT IS DAMAGED (CHIPPED, CRACKED). THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10779092 ↗

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