ATTUNE 2513-10-060Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION PRESS-FIT STEM TRIAL 10mm x 60mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295438779), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method
PATIENT UNDERWENT ATTUNE REVISION SURGERY. AN INSTRUMENT (TRIAL STEM) WAS LEFT IN PATIENT FEMUR DIAPHYSIS UNNOTICED. IT WAS DISCOVERED DURING CONTROL X-RAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO CLINICAL OUTCOMES REPORTED BY THE SURGEON.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23809663 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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