JOURNEY 74012646Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556003398), received between Sep 25, 2020 and Nov 23, 2020 — classified as 2 malfunctions.

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.

• MalfunctionNov 23, 2020Break; Break

  IT WAS REPORTED THAT IN A TIBIAL SPACER BLOCK WIDE, THE PLASTIC RING INSIDE IS BROKEN, THEREFORE THE ORANGE SHINS DO NOT CLICK IN. TKA PROCEDURE WAS PERFORMED. PROCEDURE FINISHED WITH THE SAME DEVICE. THIS OCCURRED AFTER PROCEDURE. NO SURGICAL DELAY. NO HARM OR INJURY REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886923 ↗
• MalfunctionSep 25, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT DEVELOPED A CHIP. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10587478 ↗

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