JOURNEY 74036058Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556691724), received between Nov 4, 2022 and Mar 31, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K190085); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture; Material Fragmentation

  IT WAS REPORTED THAT, DURING A UKA, THE SURGEON FELT LIKE SOMETHING WAS CATCHING DURING REPEATED FLEXION AND EXTENSION, IT WAS NOTICED THAT THERE WERE GREEN SHAVINGS INTO THE PATIENT'S BODY. THEREFORE, WHEN ONE (1) JRNY II UK MED INSERT TRIAL SZ 7-8 8MM WAS CHECKED, IT WAS FOUND TO BE SHAVED. THE PIECES WERE REMOVED FROM THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750493 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) JRNY II UK MED INSERT TRIAL SZ 7-8 8MM BROKE DURING TRIALING DUE TO THE KNEE BEING DESCRIBED AS ¿SUPER TIGHT¿. 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 24520667 ↗
• MalfunctionJul 22, 2025Fracture; Scratched Material; Fracture; Scratched Material

  IT WAS REPORTED THAT, DURING UKA SURGERY, ONE (1) JRNY II UK MED INSERT TRIAL SZ 7-8 8MM WAS CHIPPED AND SCRATCHED DUE TO CONTINUOUS USE. BROKEN PIECES WERE REMOVED VIA PICK UPS 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 22562680 ↗
• MalfunctionOct 1, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A UKR SURGERY, AFTER TRIALING AND UPON REMOVAL, IT WAS NOTICED THAT THE PLASTIC OF ONE (1) JRNY II UK MED INSERT TRIAL SZ 7-8 8MM WAS BREAKING OFF DUE TO SIGNIFICANT DAMAGE. AS A RESULT, GREEN PLASTIC FLAKES WERE LEFT ON THE TIBIAL TRIAL USED. THE PROCEDURE RESUMED, WITHOUT 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 20344511 ↗
• MalfunctionNov 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UKA SURGERY, THE JRNY II UNI MED INSERT TRIAL SZ 7-8 8MM DEVICE BROKE AT EXTRACTION HOLE WHILE REMOVING IT. 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 15726771 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190085. One submission often covers many models, so check the product and lot details in each record.

• Z-1393-2023 · Mar 27, 2023 · Open, Classified
  JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
• Z-2133-2020 · Jan 28, 2020 · Terminated
  JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti
• Z-2132-2020 · Jan 28, 2020 · Terminated
  JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of moti