ATTUNE 1520-20-408Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT AOX 4, 8mm · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295542438), received between Mar 7, 2024 and Jun 9, 2026 — classified as 7 injuries.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- Insufficient Information2
- Joint Laxity2
- Pain2
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT (I&D) ALONG WITH A POLY SWAP. DOI: (B)(6), 2026 DOR: (B)(6), 2026 AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 25447690 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Pain
MAUDE report 24816098 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO INSTABILITY, A THICKER POLY NEEDED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 22676225 ↗InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INSTABILITY ON THE RIGHT SIDE. REVISION SURGERY WAS PERFORMED. THE 8MM INSERT WAS REPLACED WITH A 10MM INSERT.
Patient problems: Joint Laxity
MAUDE report 22289218 ↗InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP FOR INFECTION ON AN UNKNOWN DATE. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22186702 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A POLY REMOVAL FOR I&D. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 20461212 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Pain
MAUDE report 18861895 ↗
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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