JOURNEY 74034251Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556003046), received between Sep 9, 2020 and Oct 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K140555); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT, ONE JRNY II BCS CONST ISRT TRL S5-6 9MM RT IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592148 ↗
• InjuryMar 30, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT NINE YEARS AND FOUR MONTHS AFTER A JRNY II BCS CONST ISRT TRL S5-6 9MM RT INSERT HAD BEEN IMPLANTED A REVISION SURGERY WAS PERFORMED BECAUSE THE INSERT FAILED. THE INSERT LOOKED LIKE IT HAD BEEN WORN DOWN, IT WAS REPLACED WITH A BACKUP. NO COMPLICATIONS WERE REPORTED. IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

  Patient problems: Failure of Implant

  MAUDE report 11592818 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS CONST INSERT TRIAL S5-6 9MM RIGHT HAS CHIPPED AT A BASE. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10511308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140555. 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