ATTUNE 1518-20-807Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED LEFT AOX 8, 7mm · Class 2 · Implant
All models of ATTUNE (1475)
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 10603295541905), received between Apr 11, 2024 and Mar 20, 2026 — classified as 4 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 Problem4
Patient problems
- Unspecified Infection3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24647900 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A LEFT TOTAL KNEE DONE ON (B)(6), 2024. THE KNEE BECAME INFECTED AND THE PATIENT WAS BROUGHT IN FOR RESECTION. ALL COMPONENTS WERE REMOVED AND AN ARTICULATING KNEE SPACER WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 23454301 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE IMPLANT REMOVAL PROCEDURE DUE TO INFECTION. DOI: (B)(6) 2024, DOE: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 20736990 ↗InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT REVISION INVOLVING A BILATERAL POLY SWAP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 19088089 ↗
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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