ATTUNE 2545-00-187Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM EVALUATION BULLET NON-CEMENTED SIZE 1-10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295419716), received between May 17, 2024 and Jun 17, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information3
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Break
IT WAS REPORTED THAT THE LOCKING RING ON THE FLOATING TIBIA EVAL BULLET HAD FALLEN OFF AFTER GOING THROUGH THE WASH. A REPLACEMENT WAS REQUESTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534650 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTORS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22475132 ↗MalfunctionJul 10, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTORS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22475121 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758103 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758073 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21758041 ↗MalfunctionFeb 3, 2025Break; Break
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT RING IS DAMAGED THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21297324 ↗MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED THAT THE EVAL BULLET WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 19709137 ↗MalfunctionMay 17, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BULLET WILL NOT SNAP INTO THE TIBIA.
Patient problems: Insufficient Information
MAUDE report 19339933 ↗MalfunctionMay 17, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BULLET WILL NOT SNAP INTO THE TIBIA.
Patient problems: Insufficient Information
MAUDE report 19339925 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page