JOURNEY II XR 74023862Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II XR ARTICULAR INSERT XLPE LATERAL SIZE 5-6 LEFT 10MM · Class 2 · Implant
All models of JOURNEY II XR (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556615768), received between Jul 23, 2018 and Apr 30, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K152726, 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
- Insufficient Device Problem Information3
- Loss of Osseointegration1
Patient problems
- Injury4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE ARTHROFIBROSIS. ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.
Patient problems: Injury
MAUDE report 10013909 ↗InjuryNov 26, 2019Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE ISSUE.
Patient problems: Injury
MAUDE report 9378522 ↗InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS OF LEFT KNEE.
Patient problems: Injury
MAUDE report 9313361 ↗InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.
Patient problems: Injury
MAUDE report 7711897 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152726, K230653. One submission often covers many models, so check the product and lot details in each record.
- 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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