ATTUNE 2504-40-606Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CONVENTIONAL CUT GUIDE SIZE 6 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295438458), received between Sep 22, 2021 and Dec 8, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THAT THE SIZE 8 CONV CUTTING GUIDE INSTRUMENT BROKE, HOWEVER, IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743282 ↗MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THAT SIZE 8 CONV CUTTING GUIDE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743084 ↗MalfunctionMar 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN WAS STUCK INSIDE INSTRUMENTS BECAUSE IT WAS BENT AND COULD NOT SEPARATE.
Patient problems: Insufficient Information
MAUDE report 21684018 ↗MalfunctionJun 13, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SCREW HOLE CROSS THREADED. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674299 ↗MalfunctionSep 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 4-7 TRIAL BOLT THAT ATTACHES TO THE CUT BLOCK TO BROACH TRIAL GOT STUCK AND SIEZED UP. THEY WERE NOT ABLE TO LOOSEN UP AND HAD TO USE ANOTHER SET FOR THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12512858 ↗
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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