ATTUNE 1520-20-305Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT AOX 3, 5mm · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295542322), received between Apr 2, 2024 and Oct 25, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (1 report).
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 Problem1
- Difficult to Open or Remove Packaging Material1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN FOR AN EXPLANT AND REPLANT DUE TO INFECTION. THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS THEMSELVES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 20537638 ↗MalfunctionApr 2, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR THE KNEE JOINT WITH THE IMPLANT IN QUESTION. BEFORE SURGERY, WHEN THE NURSE (CLEAN) OPENED AND TOOK OUT THE IMPLANT IN QUESTION, THERE WAS NO GAP OR PLACE TO PICK IT OUT ON THE BLISTER PACK LID, AND THE LID WAS IN THE WAY AND COULD NOT BE TAKEN OUT. BECAUSE THERE WAS NO CHOICE, ANOTHER NURSE (UNCLEAN) DROPPED THE IMPLANT IN QUESTION ON THE CLEANLINESS TABLE WITH THE IMPLANT CASE FACING DOWNWARDS. TO PREVENT THE CASE FROM BECOMING UNCLEAN, THERE WAS A REQUEST TO IMPROVE THE LID BY ADDING A GAP OR A PLACE TO PICK IT UP, AS IN OTHER IMPLANT CASES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19018150 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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