JOURNEY 74035281Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556157336), received between Aug 21, 2019 and Mar 29, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM LT BROKE IN HALF ON FLEXION EXTENSION ROM. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006706 ↗
• MalfunctionFeb 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 9MM LEFT WAS CHIPPED TOO MUCH. SINCE THIS WAS NOTICED DURING A FIELD INSPECTION, NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446599 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT, A PLASTIC PIECE OF THE JRNY II BCS ART ISRT TRL SZ 7-8 9MM LT BROKE DURING THE TRIAL. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289725 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A FIELD INSPECTION, A JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 9 MM LEFT WAS FOUND BROKEN. 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 12136330 ↗
• InjuryJun 23, 2021Break; Break

  IT WAS REPORTED THAT ON JUNE 10TH, DURING A TKA SURGERY, A JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 9MM LEFT BROKE INSIDE THE PATIENT DURING IMPACTING. ALL PIECES WERE RETRIEVED, THE PATIENT SUFFERED NO HARM. IT WAS MENTIONED THAT THERE WAS A CRACK IN THE TRIAL BEFOREHAND. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE AND WITHOUT DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054023 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT, A JRNY II BCS ART ISRT TRL SZ 7-8 9MM LT BROKE. AS THIS WAS NOTICE DURING THE POST CASE WASHING CYCLE, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807402 ↗
• InjuryJan 18, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE, THE TRIAL CRACKED DURING FLEXION INSIDE THE PATIENT. ALL PIECES WERE RECOVERED, NO PATIENT AFFECTATION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PROCEDURE FINISHED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189349 ↗
• InjuryJan 4, 2021Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE POLY TRIAL CRACKED DURING IMPACTING - NO HARM TO PATIENT. FINISHED CASE WITH SAME DEVICE. NO PIECES LOST TO PT. NO DELAY TO CASE. NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11114824 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT DURING WASHING CYCLE JOURNEY II BCS ARTICULAR INSERT TRIAL SIZE 7-8 9MM LEFT BROKE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11083577 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT THE JOURNEY II BCS ART INSERT TRIAL SIZE 7-8 9MM LEFT BROKE. IT IS UNKNOWN WHETHER THE INCIDENT HAPPENED OR NOT IN A SURGICAL ENVIRONMENT OR IF THERE WAS ANY PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013762 ↗
• 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 10322136 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ITEM BROKE IN HALF UPON IMPACTION. NO HARM TO THE PATIENT WAS RECORDED. NO DELAY AND NO BROKEN PIECE FELL INTO THE PATIENT. SN BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914954 ↗

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