ATTUNE 2545-00-341Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM FIXED BEARING FLOAT EVALUATION BULLET SIZE 1-10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295446408), received between May 31, 2023 and May 5, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device-Device Incompatibility3
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE FB FLOATING BULLET WAS BENT AND WILL NO LONGER FIT IN TIBIAL TRAY APPROPRIATELY. ALSO, THE BLACK PATELLA BUTTON FOR THE CLAMP WAS TORN IN HALF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21959493 ↗MalfunctionMay 5, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE FB FLOATING BULLET WAS BENT AND WILL NO LONGER FIT IN TIBIAL TRAY APPROPRIATELY. ALSO, THE BLACK PATELLA BUTTON FOR THE CLAMP WAS TORN IN HALF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21959365 ↗MalfunctionJan 7, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE CHIPPED AND NOT PASSED THROUGH BY SPD. THERE WAS NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092779 ↗MalfunctionJan 7, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE CHIPPED AND NOT PASSED THROUGH BY SPD. THERE WAS NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092766 ↗MalfunctionJan 7, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE CHIPPED AND NOT PASSED THROUGH BY SPD. THERE WAS NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092738 ↗MalfunctionMay 31, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE METAL RING WAS SITTING PROUD ON THE FB FLOAT EVALUATION BULLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032306 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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