ATTUNE 2504-40-206Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FEMORAL CTT TRIAL RIGHT SIZE 6 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295439790), received between Oct 17, 2019 and Dec 12, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
- Corroded1
- Device-Device Incompatibility1
- Naturally Worn1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE WERE DIRTY INSTRUMENTS IN THE ATTUNE CORE INSTRUMENTS TRAY. THIS HAPPENED AT 3PL AND ACCORDINGLY QUALITY ISSUE HAS BEEN SET UP IN ETQ NR-0210271. (B)(4).
Patient problems: Insufficient Information
MAUDE report 18309495 ↗MalfunctionJul 24, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE THREADS FOR THE BOX TRIAL TO ATTACH TO ON THE 6 RIGHT REVISION CUT THROUGH FEMUR ARE CROSS THREADED. IT WON¿T ALLOW THE BOX TO BE SCREWED DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17381316 ↗MalfunctionOct 17, 2019Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9203885 ↗
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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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