ATTUNE 1520-20-710Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT AOX 7, 10mm · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 16, 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 10603295542605), received between Feb 1, 2023 and Jun 26, 2026 — classified as 5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Joint Laxity3
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION WITH POTENTIAL REMOVAL OF DEPUY COMPONENTS. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED DEPUY SYNTHES PRODUCTS USED: DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150400207. LOT NUMBER: D24045025. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE C/RET FEM RT SZ 7. CEMENTED. CATALOG NUMBER: 150670007. LOT NUMBER: D24070812. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB CEMENTED TIBIAL. BASE SIZE 7. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 151821038. LOT NUMBER: 356421. COMPONENT TYPE: PATELLA. DESCRIPTION: ATT MED DOME PAT 38MM POR. CATALOG NUMBER: 152020710. LOT NUMBER: M5721R. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE RIGHT MEDIAL. STABILIZED INSERT SIZE 7 10MM.
Patient problems: Joint Laxity
MAUDE report 25637588 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO THE FEMORAL COMPONENT DISLODGING AND ROTATING ANTERIORLY, THE KNEE WAS REVISED IN ITS ENTIRETY. THE FEMORAL COMPONENT, TIBIAL COMPONENT AS WELL AS POLY INSERT WERE REMOVED FROM THE PT. AND FIELD, THERE WAS NO DELAY TO THE CASE NOR HARM DONE TO THE PATIENT. THERE WAS AN ATTEMPT TO SALVAGE THE PRIMARY CONSTRUCT, BUT THERE WAS NO WAY TO RECONSTRUCT THE FEMUR PROPERLY. AFFECTED SIDE RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 25394820 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED: 1. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? RIGHT. 2. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. 3. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO.
Patient problems: Joint Laxity
MAUDE report 24133777 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED AND UNDERWENT POLY EXCHANGE FOR INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22298900 ↗InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE GETTING MOTION SO THE SURGEON DID A SOFT TISSUE RELEASE AND EXCHANGED THE POLY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Loss of Range of Motion
MAUDE report 16276912 ↗
Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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