JOURNEY 74033614Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010671974), received between Dec 21, 2020 and Oct 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SURGEON HIT THE POLY IN WITH A BONE TAMP AND ONE (1) UNIV ISRT SPACER SZ 1-2 13M BROKE. THE PROCEDURE RESUMED WITHOUT ANY DELAY; HOWEVER, IT REMAINS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20420034 ↗
• MalfunctionApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE UNIV ISRT SPACER SZ 1-2 13M FRACTURED AFTER REMOVING FROM THE TIBIA. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN S+N BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714554 ↗
• MalfunctionApr 18, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION IN WAREHOUSE THE DEVICES WERE FOUND DEFECTIVES. THE TIBIAL SPACER BLOCK STANDAR WAS NOTICED WITH AN UNSPECIFIC FAILURE MODE (CASE: (B)(4)). THE JOURNEY FEMORAL IMPLANT IMPACTOR BUMPER RIGHT (CASE: (B)(4)) WAS NOTICED BROKEN. THE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 1-2 12 MM LEFT (CASE: (B)(4)), UNIVERSAL INSERT SPACER SIZE 1-2 18 MM (CASE: (B)(4)), JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 8 MM (CASE: (B)(4)), UNIVERSAL INSERT SPACER SIZE 1-2 13 MM (CASE-2021-00047028-6) AND JOURNEY UNI TIBIA TRIAL INSERT SIZE 3-4/ 9 MM (CASE: (B)(4)) WERE NOTICED CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683538 ↗
• MalfunctionDec 21, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICE WAS FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047114 ↗

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