JOURNEY 74029215Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II BCS CONSTRAINED ARTICULAR INSERT SIZE 1-2 RIGHT 13MM · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 18, 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 00885556174210), received between Jan 9, 2020 and Dec 1, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Connection Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K140555, K230653); 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.
Most reported problems
Device problems
- Connection Problem1
- Insufficient Device Problem Information1
Patient problems
- Injury1
- 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.
InjuryDec 1, 2020Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING TKA PROCEDURE THE JRNY II BCS CNSTRD ART ISRT 1-2 RT 13M, JRNY II BCS CNSTRD ART ISRT 1-2 RT 15M AND JRNY II ISRT XLPE DD RT SZ 1-2 15MM WOULD NOT LOCK INTO PLACE. THIS HAPPENED DURING USE INSIDE THE PATIENT. THERE WAS NO DELAY GREATER THAN 30 MIN. S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10928229 ↗InjuryJan 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN, A FEELING OF WRONGNESS, AND FRACTURE. THE JOURNEY II INSERT WAS EXPLANTED.
Patient problems: Injury
MAUDE report 9568721 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140555, K230653. One submission often covers many models, so check the product and lot details in each record.
- Z-0157-2024 · Sep 27, 2023 · Open, ClassifiedJOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
- Z-0158-2024 · Sep 27, 2023 · Open, ClassifiedJOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
- Z-2621-2023 · Aug 31, 2023 · Open, Classifiedsmith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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