Skip to content

JOURNEY 74016408Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK RESECTION ANTERIOR/POSTERIOR BLOCK LEFT MEDIAL/RIGHT LATERAL SZ 8 · Class 2

All models of JOURNEY (566)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556689998), received between Mar 23, 2021 and Jul 20, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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

Device problems

  • Device Reprocessing Problem1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • InjuryJul 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT, DURING A TKA SURGERY, A DRILL COULD NOT DRILLED THROUGH A JRNY II UNI RESECT FINISH TRL LM/RL SZ 8 AND A LARGE AMOUNT OF METAL LINT WAS GENERATED. THE DRILLING WAS CONDUCTED BY FREEHAND. IT IS UNKNOWN IF ANY POTENTIAL METAL DEBRIS ENTERED THE SURGICAL SITE AND IF AN ADDITIONAL INTERVENTION WAS NECESSARY TO RETRIEVE THE METAL LINT. SURGERY WAS FINISHED, AFTER A NON-SIGNIFICANT DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15064596 ↗
  • MalfunctionMar 23, 2021Device Reprocessing Problem; Device Reprocessing Problem

    IT WAS REPORTED THAT THE LUG HOLE OF THE FINISHING GUIDE HAS METAL SHAVINGS INSIDE FROM DRILL BIT ((B)(4)) AND IS NOT FUNCTIONAL. THIS FAILURE WAS NOTICED DURING PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11552215 ↗

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-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
  • 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

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page