JOURNEY 74016407Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556689981), received between Jun 18, 2020 and Oct 16, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Flaked” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Flaked; Difficult to Insert; Flaked; Difficult to Insert

  IT WAS REPORTED THAT, WHILE PERFORMING THE UKR PROCEDURE WITH A JOURNEY II UKR LOAN SET, THE FEMORAL LUGS WERE PREPARED WITH THE FEMORAL PEG DRILL THROUGH ONE (1) JRNY II UK RESECT AP BLOCK LM/RL SZ 7. IT WOULD NOT PASS THROUGH SMOOTHLY, AND IT WAS NOTICED WHEN IT FINALLY WENT THROUGH AND WAS RETRACTED, THERE WAS A SLIVER OF METAL DEBRIS. MORE THAN ONE PIECE WAS NOTICED AND ALL WERE REMOVED FROM THE PATIENT AND THE BLOCK. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940604 ↗
• InjuryJun 18, 2020Flaked; Device Damaged by Another Device; Flaked; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING USE WHEN THE INSTRUMENT WAS INSIDE THE PATIENT, PRODUCED METAL SHAVING WHEN CONTACTED BY THE DRILL IN THE FEMUR PREP PROCESS. THERE WAS A DELAY BETWEEN 0-30 MIN. THE SURGERY WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10172119 ↗

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