JOURNEY 74033651Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556421888), received between Sep 4, 2020 and Oct 30, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) JRNY II CR ISRT TRL RT SZ 5-6 9M BROKE WHEN IMPACTING THE FEMUR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430894 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHILE REMOVING THE JRNY II CR ISRT TRL RT SZ 5-6 9M, THE POSTERIOR MEDIAL SIDE GOT CAUGHT UP ON THE FEMORAL TRIAL AND BROKE OFF. IT WAS NOTICED IMMEDIATELY, AND BOTH PIECES OF PLASTIC WERE REMOVED BY HAND. IT WAS DESCRIBED AS A CLEAN FRACTURE, SO NO PIECES LEFT INSIDE THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830553 ↗
• MalfunctionFeb 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT ONE (1) JRNY II CR ISRT TRL RT SZ 5-6 9M SNAPPED IN HALF WHILE BEING INSERTED DURING TRIALING. PICK UPS AND SUCTION WERE USED TO REMOVE ANY FRAGMENTS THAT MAY HAVE EXISTED IN THE PATIENT AT THE TIME OF BREAKAGE. 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 18797030 ↗
• MalfunctionNov 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE TRIALING, A JRNY II CR ISRT TRL RT SZ 5-6 9M HAD A PIECE BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACKUP DEVICE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166926 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, A JOURNEY II CR INSERT TRIAL RIGHT SIZE 3-4 9MM BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655095 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT A PIECE WAS BROKEN OFF THE POSTERIOR PORTION OF THE JRNY II CR ISRT TRL RT SZ 5-6 9M. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED DUE TO THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454950 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT THE JRNY II CR ISRT TRL RT SZ 5-6 9M WAS BROKEN AT THE TOP. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14417408 ↗
• InjuryApr 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER TRIALING, THE POSTERIOR MEDIAL ASPECT OF THE JRNY II CR ISRT TRL RT SZ 5-6 9M SNAPPED OFF WHEN WAS BEING REMOVED. ALL PIECES WERE REMOVED FROM PATIENT. SURGERY RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074210 ↗
• MalfunctionFeb 10, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING CLEANING, IT WAS NOTICED THAT THE JRNY II CR ISRT TRL RT SZ 5-6 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 13508865 ↗
• InjuryMar 15, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JOURNEY II CR INSERT TRIAL RIGHT SIZE 5-6 9MM BROKE WHEN RETRIEVING THE TRIAL PRIOR TO IMPLANTING THE INSERT. NO FURTHER INFORMATION WAS PROVIDED. 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 11479190 ↗
• InjuryNov 26, 2020Break; Break

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY, THE INSERT TRIAL CRACKED. THE INSERT TRIAL BROKE AFTER THE FEMUR AND TIBIA HAD ALREADY BEEN CEMENTED. SMALL PIECE WAS STUCK IN THE BACK OF THE KNEE. SURGEON WAS ABLE TO RETRIEVE THE SMALL BROKEN PIECE FROM THE BACK OF THE KNEE. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911446 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT THE JRNY II CR ISRT TRL RT SZ 5-6 9M WAS FOUND TO BE BROKEN DURING A ROUTINE EFIP INSPECTION. THERE WERE NO REPORTED PROBLEMS FROM ANY CASES.

  Patient problems: No Patient Involvement

  MAUDE report 10497724 ↗