JOURNEY 74031593Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556275917), received between Jun 4, 2021 and Jun 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT A JOURNEY FEM IMPACT BUMPER LT ((B)(4)) HAD A PIECE MISSING A LUG ON BOTTOM AND CRACKED. THE GROOVES THAT SLIDE ONTO THE JRNY II TKA FEM TRIAL SZ 3 LT ((B)(4)) WERE STRIPPED AND IT DID NOT LOAD PROPERLY, AND ALSO A JOURNEY ART ISRT ASSM TOOL ((B)(4)) HAD NO TENSION AND DID NOT WORK TO SEAT POLY. DEVICES OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK UP DEVICES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942560 ↗

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