JOURNEY II XR 74022297Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II XR BASEPLATE SIZE 7 RIGHT · Class 2 · Implant
All models of JOURNEY II XR (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556615454), received between Aug 11, 2019 and Sep 30, 2020 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
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
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
- Physical Resistance/Sticking1
Patient problems
- Injury5
- Cellulitis1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CLINICAL SUBJECT EXPERIENCED A FALL AND DEVELOPED CELLULITIS AS A RESULT OF IT. THE PATIENT UNDERWENT AN ASPIRATION WHICH DETERMINED THERE WAS PRESENCE OF A RIGHT KNEE INFECTION. THE EVENT WAS TREATED VIA REVISION SURGERY TO REMOVE THE AFFECTED COMPONENTS.
Patient problems: Cellulitis; Injury; Unspecified Infection
MAUDE report 10604544 ↗InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE EFFUSION AND HEMARTHROSIS. THE EVENT WAS TREATED VIA ABLATION AND ARTHROSCOPY.
Patient problems: Injury
MAUDE report 9900946 ↗InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE EFFUSION AND HEMARTHROSIS. THE EVENT WAS TREATED VIA ABLATION AND ARTHROSCOPY.
Patient problems: Injury
MAUDE report 9900945 ↗InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.
Patient problems: Injury
MAUDE report 9900925 ↗InjuryAug 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED RIGHT TIBIAL SPINE FRACTURE AND ACL DEFICIENCY POST OPERATIVE.
Patient problems: Injury
MAUDE report 8881971 ↗
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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