ATTUNE 2547-09-004Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION DISTAL FEMORAL AUGMENT TRIAL 16MM X SIZE 9-10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295439608), received between May 14, 2025 and Jun 4, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Corroded” (4 reports).
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
- Corroded4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Corroded; Corroded
THERE IS RUSTING ON BOTH SIDES OF THE AUGMENT TRIAL AND IT COVERS THE PRODUCT INFORMATION (SERIAL AND BATCH INFORMATION). THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142413 ↗MalfunctionJun 4, 2025Corroded; Corroded
THERE IS RUSTING ON BOTH SIDES OF THE AUGMENT TRIAL AND IT COVERS THE PRODUCT INFORMATION (SERIAL AND BATCH INFORMATION). THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142351 ↗MalfunctionMay 14, 2025Corroded; Corroded
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE TWO TRIALS. THE PRODUCT WAS NOT DAMAGED JUST IS RUSTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019360 ↗MalfunctionMay 14, 2025Corroded; Corroded
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE TWO TRIALS. THE PRODUCT WAS NOT DAMAGED JUST IS RUSTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019358 ↗
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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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