JOURNEY 74033661Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556421857), received between Jun 26, 2019 and Nov 21, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN THE SURGEON HIT ONE (1) JRNY II CR ISRT TRL LT SZ 5-6 9M IN, THE FRONT PART CHIPPED OFF. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622013 ↗
• MalfunctionMay 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II CR ISRT TRL LT SZ 5-6 9M BROKE IN HALF. THE SURGEON PULLED ALL THE PIECES FROM THE PATIENT WITH HIS HAND AND ACCOUNTED THEM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073900 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE SERVING, A SMALL PIECE OF ONE (1) JRNY II CR ISRT TRL LT SZ 5-6 9M BROKE OFF. ALL PIECES WERE ACCOUNTED FOR USING A PITUITARY RONGUE. THERE WAS NO SURGICAL DELAY; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994960 ↗
• MalfunctionJul 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE JRNY II CR ISRT TRL LT SZ 5-6 9M WAS CHIPPED AND UNUSABLE. 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 15057395 ↗
• MalfunctionNov 23, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED AND OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861443 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP, BEFORE A TKA THE JRNY II CR ISRT TRL LT SZ 5-6 9M PLASTIC CHIPPED. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11497563 ↗
• MalfunctionDec 6, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE JOURNEY II CR INSERT TRIAL BROKE DURING CLEANING PROCESS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10955750 ↗
• MalfunctionDec 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE IN THE JRNY II CR ISRT TRL LT SZ 5-6 9M IT WAS NOTICED THAT A SMALL PIECE OF MATERIAL HAD COME OFF. NO INFORMATION ABOUT SURGICAL DELAYS, S+N BACKUP DEVICES OR WHEN THIS INCIDENT HAPPENED WAS INITIALLY PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10932131 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSERT TRIAL BROKE IN HALF WHILE IT WAS USED FOR TRIALING THE KNEE. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644076 ↗
• MalfunctionJul 24, 2019Break; Break

  IT WAS REPORTED THAT THE TRIAL SNAPPED WHILE TRIALING. NO BACKUP DEVICE AVAILABLE. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824272 ↗
• MalfunctionJun 26, 2019Break; Break

  IT WAS REPORTED THAT DURINGA TKA PROCEDURE THE DEVICE BROKE WHILE SURGEON WAS TRAILING. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737423 ↗