JOURNEY 74036059Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556691731), received between Jun 17, 2022 and Oct 1, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A UKR SURGERY, AFTER TRAILING AND UPON REMOVAL, IT WAS NOTICED THAT THE PLASTIC OF ONE (1) JRNY II UK MED INSERT TRIAL SZ 7-8 9MM 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 20344864 ↗
• MalfunctionJun 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE JRNY II UK MED INSERT TRIAL SZ 7-8 9MM BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577027 ↗
• InjuryJun 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHEN REMOVING THE JRNY II UNI MED INSERT TRIAL SZ 7-8 9MM, THE HOLE IN WHICH THE REMOVAL TOOL, SPLIT. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14738528 ↗

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