JOURNEY 74035262Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556157084), received between Apr 9, 2019 and Feb 12, 2026 — classified as 1 injury, 5 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.

• MalfunctionFeb 12, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II BCS ART ISRT TRL SZ 5-6 10MM LT GOT DAMAGED WHILE INSERTING. THE GROOVES UNDERNEATH BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322427 ↗
• MalfunctionNov 4, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS ART INSERT TRIAL SIZE 5-6 10 MM LEFT IS DAMAGED (CHIPPED, CRACKED). THERE WAS NO CASE INVOLVED AS IT WAS NOTICED UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10785475 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED THAT A JOURNEY II BCS ART INSERT TRIAL SIZE 5-6 10MM LEFT WAS RETURNED CHIPPED AND WITH BURRS. NO CASE INVOLVED. THIS WAS FOUND DURING INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10766582 ↗
• MalfunctionJun 25, 2020Crack; Crack

  IT WAS REPORTED THE DEFECTIVE DEVICE WAS FOUND DURING WAREHOUSE INSPECTION. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10194393 ↗
• InjuryFeb 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT IT WAS THE FIRST TIME TRIALS WERE USED AND THE PLASTIC CUT AND PEELED OFF LEAVING PIECES OF YELLOW PLASTIC IN THE JOINT. DR. COULD BE ROUGH ON INSTRUMENTS BUT HE WAS ONLY PUTTING IT IN BY HAND WITHOUT EXCESSIVE FORCE. A BACKUP DEVICE WAS AVAILABLE. IT IS NOT KNOWN IF SURGERY WAS DELAYED.

  Patient problems: Injury

  MAUDE report 9744708 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED THAT DURING TKA THE POLY BROKE ON MEDIAL CONCAVE SIDE. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497562 ↗

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