JOURNEY 74016417Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556690086), received between Mar 9, 2021 and Jun 26, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• MalfunctionJun 26, 2023Material Fragmentation; Device Damaged by Another Device; Material Fragmentation; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING A UKR SURGERY, THE LUG DRILL WAS DIFFICULT TO PASS THROUGH THE PREPARATION HOLE OF ONE (1) JRNY II UNI RESECT AP BLOCK RM/LL SZ 7, THERE WAS A SIGHT OF SMOKE. WHEN PREPARATION WAS COMPLETED IT WAS NOTED THAT THERE WAS METAL DEBRIS IN THE HOLE, WHICH WAS REMOVED. ON REMOVAL AND INSPECTION OF THE BLOCK, THE AREA OF DAMAGE WAS SEEN, AND A FURTHER SPEC OF DEBRIS WAS SEEN. FURTHERMORE, SOME METAL DEBRIS WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199070 ↗
• InjuryMar 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY, THE POSTERIOR LUG HOLE IN THE JOURNEY II UNI RESECTION AP BLOCK RM/LL SZ 7 LEFT METAL DEBRIS IN THE PATIENT WHEN DRILLING. PROCEDURE CONTINUED WITH THE SAME DEVICE, WITH A DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT. 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 11444085 ↗

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