Skip to content

JOURNEY 74016404Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK RESECTION ANTERIOR/POSTERIOR BLOCK LEFT MEDIAL/RIGHT LATERAL SZ 4 · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556689950), received between Jun 18, 2020 and Nov 16, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Damaged by Another Device1
  • Flaked1
  • Material Fragmentation1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryNov 16, 2021Material Fragmentation; Device Damaged by Another Device; Material Fragmentation; Device Damaged by Another Device

    IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, WHILE DRILLING OF POSTERIOR LUG HOLE, A FEMORAL PEG DRILL BOUND IN A JOURNEY II CUTTING BLOCK AND SHED METAL SHAVINGS INSIDE THE PATIENT. THE CUTTING BLOCK WAS DAMAGED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12820495 ↗
  • InjuryJun 18, 2020Flaked; Flaked

    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

    MAUDE report 10172116 ↗

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

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.