ATTUNE 1518-20-510Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED LEFT AOX 5, 10mm · Class 2 · Implant
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295541684), received between Jun 17, 2025 and Aug 28, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 Problem5
- Device Damaged Prior to Receipt by User1
Patient problems
- Unspecified Infection4
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the poly exchanged during an I&D. Revision was for infection.Affected side: Left Knee.
Patient problems: Unspecified Infection
MAUDE report 50498307 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE POLY WAS UPSIZED. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 25635010 ↗MalfunctionFeb 3, 2026Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT THE MS INSERT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250965 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS INFECTED TOTAL KNEE. SURGEON TOOK OUT OLD PARTS AND PUT IN A SPACER. AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24039245 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED WITH POLY SWAP FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.
Patient problems: Unspecified Infection
MAUDE report 23961125 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT GOT INFECTED AND THE SURGEON REMOVED THE IMPLANTS TO DO A SPACER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22243485 ↗
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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