JOURNEY 74016403Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY II UK RESECTION ANTERIOR/POSTERIOR BLOCK LEFT MEDIAL/RIGHT LATERAL SZ 3 · Class 2

All models of JOURNEY (566)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556689943), received between Nov 7, 2024 and Nov 7, 2024 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Damaged by Another Device1
Flaked1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 7, 2024Flaked; Device Damaged by Another Device; Flaked; Device Damaged by Another Device
IT WAS REPORTED THAT DURING A UKA SURGERY, THE FEMORAL IMPLANT REQUIRED TWO PEG HOLES TO BE DRILLED USING THE FEMORAL PEG DRILL. WHILE DRILLING THE POSTERIOR PEG, SLIGHT TILTING OF THE DRILL CAUSED ABRASION TO THE JRNY II UK RESECT AP BLOCK LM/RL SZ 3 IN THE LAST 3¿4 MM, RESULTING IN METAL CHIPPING. DESPITE THIS ISSUE, THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO INJURIES WERE REPORTED, AND NO FRAGMENTS FELL INTO THE WOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630409 ↗

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

Device details

UDI-DI	`00885556689943`
Brand	JOURNEY
Model	74016403
Company	Smith & Nephew, Inc.
Product code	HSX · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Class	Class 2
FDA submission	K190085
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Orthopaedic reamer guide

An orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

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

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2 recalls2 reports
Scorpio 73-3710
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
2 recalls1 report
Scorpio 73-3110
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
2 recalls0 reports
Arthrex® AR-503-TTTE
Arthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
1 recall14 reports
Arthrex® AR-503-TTTJ
Arthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
1 recall9 reports
ENGAGE 1-10011-300
Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
1 recall7 reports
Arthrex® AR-503-TTTG
Arthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
1 recall7 reports
ENGAGE 1-10003-400
Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
1 recall6 reports

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

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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