JOURNEY 74033631Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556421956), received between Feb 23, 2021 and Mar 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING A TKA SURGERY, ONE (1) JRNY II CR ISRT TRL RT SZ 3-4 9M BROKE DURING INSERTION. 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 16584288 ↗
• MalfunctionFeb 18, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING CLEANING, IT WAS NOTICED THAT THE JRNY II CR ISRT TRL RT SZ 3-4 9M WAS FOUND CHIP AND CRACK. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559747 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT THE JRNY II CR ISRT TRL RT SZ 3-4 9M JUST NEEDS TO BE REPLACED. THE BOTTOM OF THE TRIAL IS STARTING TO FALL APART. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418858 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT THE TOP OF A JOURNEY II CR INSERT TRIAL RIGHT SIZE 3-4 9M IS CHIPPED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090803 ↗
• MalfunctionJun 28, 2021Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT, A JRNY II CR ISRT TRL RT SZ 3-4 9 M, A JRNY II CR ISRT TRL RT SZ 3-4 10 M AND A JRNY II CR ISRT TRL RT SZ 3-4 11 M ARE WORN AND UNUSABLE. AS THIS WAS NOTICE IN A FIELD INSPECTION NOT PATIENT WAS INVOLVED. AFTER VISUAL INSPECTION OF THE DEVICE IT WAS FOUND THE JRNY II CR ISRT TRL RT SZ 3-4 9 M CRACK OFF THE DEVICE, RENDERING IT INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077364 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, WAS FOUND THAT THE JOURNEY II CR INSERT TRIAL RIGHT SIZE 3-4 9MM IS CRACKED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566418 ↗
• MalfunctionMar 19, 2021Crack; Crack

  IT WAS REPORTED THAT, A JOURNEY II CR INSERT TRIAL RIGHT SIZE 3-4 9M IS VERY WORN AND CRACKED. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO DELAY WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11522614 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE, THE INSERT TRIAL BROKE OUTSIDE THE PATIENT DURING TRIALING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11365056 ↗