JOURNEY 74035241Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00885556156889), received between Jul 23, 2020 and Aug 10, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHILE REMOVING ONE JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT TO PREPARE FOR CEMENTING, THE TRIAL BROKE IN HALF DUE TO WEAR AND TEAR. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767959 ↗
• MalfunctionFeb 8, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT WAS FOUND TO BE WORN AND CHIPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670121 ↗
• InjuryOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKR, THE INSIDE PART OF THE JJRNY II BCS ART ISRT TRL SZ 3-4 9MM LT BROKE. THE PIECE WAS RETRIEVED, BUT IS UNKNOWN HOW. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT DELAY REPORTED. PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540261 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT, THE JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT WAS CHIPPED AND BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176902 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT WAS STARTING TO BREAK. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595104 ↗
• MalfunctionJun 23, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, A JRNY II BCS ART INSERT TRIAL SZ 3-4 9MM LT ((B)(4)) DID NOT SIT FLUSH WHILE TRIALING. IT WAS ALSO REPORTED THAT A GII P/S CONS HOUSING REAM DOME ((B)(4)) WAS NOTICED TO BE DULL. NO SIGNIFICANT SURGICAL DELAY OCCURRED DUE TO THIS EVENT, BUT IT IS UNKNOWN HOW WAS THE PROCEDURE CONCLUDED. NO PATIENT INJURY WAS REPORTED DUE TO THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053612 ↗
• MalfunctionJun 16, 2021Break; Break

  IT WAS REPORTED THAT A JOURNEY II BCS ART INSERT TRIAL SIZE 3-4 9MM LEFT BROKE. THIS HAPPENED AFTER USE IN PATIENT. AS THIS WAS NOTICED AFTER SURGERY THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012410 ↗
• InjuryMay 10, 2021Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT BROKE WHEN USED TO TRIAL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797946 ↗
• 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 11047924 ↗
• MalfunctionNov 5, 2020Break; Break

  IT WAS REPORTED THAT JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT IS CHIPPED. NO CASE INVOLVED.

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

  MAUDE report 10794481 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH GOUGES IN PLASTIC/CRACKS/CUTS. NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10322257 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH GOUGES/CRACKS/SCRATCHES. NO CASE INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321968 ↗
• MalfunctionJul 24, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECTION THE DEVICE WAS FOUND WITH GOUGES/CRACKS/SCRATCHES. NO CASE INVOLVED.

  MAUDE report 10321178 ↗
• MalfunctionJul 24, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE JOURNEY II BCS ARTICULAR INSERT WAS FOUND TO BE CRACKED. NO CASE INVOLVED.

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

  MAUDE report 10318383 ↗
• InjuryJul 23, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL SNAPPED WHEN THE SURGEON WAS PUTTING THE TRIAL INTO THE KNEE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. IT IS UNCLEAR WHEN THE EVENT OCCURRED AND HOW IT WAS THE PROCEDURE FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10312893 ↗

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