JOURNEY 74016416Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II UK RESECTION ANTERIOR/POSTERIOR BLOCK RIGHT MEDIAL/LEFT LATERAL SZ 6 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556690079), received between Jun 18, 2020 and Jun 18, 2020 — classified as 2 injuries.
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 16, 2026.
Most reported problems
Device problems
- Flaked2
Patient problems
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 10172126 ↗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 10172123 ↗
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, ClassifiedJOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
- Z-2132-2020 · Jan 28, 2020 · TerminatedJOURNEY 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 · TerminatedJOURNEY 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
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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