ATTUNE 2504-40-407Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION NOTCH CUT GUIDE SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 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 10603295438359), received between Jul 8, 2019 and Sep 29, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Corroded4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Corroded; Corroded
IT WAS REPORTED THAT THE DEVICE HAS RUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15503758 ↗MalfunctionJul 13, 2022Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15001305 ↗MalfunctionAug 20, 2019Corroded; Corroded
THERE IS RUST ON THE BLACK CLIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8912755 ↗MalfunctionJul 8, 2019Corroded; Corroded
(B)(6) HOSPITAL - BEFORE USE ON PATIENT; INSTRUMENTS ARE RUSTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8768802 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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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