ATTUNE 2506-20-101Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL CEMENTED REAMER BUSHING · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 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 10603295436041), received between May 9, 2019 and May 11, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- 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.
MalfunctionMay 11, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING SURGERY, THE SURGEON DECIDED TO USE AN RP REVISION TRAY, WHEN THE LONG DRILL WAS PASSED THROUGH THE TIBIAL DRILL TOWER WITH BUSHING AND THERE WAS DIFFICULTY GETTING THE INNER BUSHING TO RELEASE FROM THE REAMER AFTER DRILLING WAS COMPLETE, BUT EVENTUALLY IT WAS ABLE TO GET FREE. EVERYTHING WENT FINE IN SURGERY. WHILE CLEANING INSTRUMENTS IT WAS NOTICED THAT THE INNER BUSHING IS SLIGHTLY WARPED AND NEEDS TO BE REPLACED. TWO SEPARATE 14 MM REAMERS WERE PASSED THROUGH FROM DIFFERENT SETS THROUGH BUSHING AND THEY ARE BOTH CATCHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16913328 ↗MalfunctionNov 16, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BOTH TOWER AND BUSHING NO LONGER FIT TOGETHER. TOWER IS BENT AND NO LONGER FIT THE BUSHING INSIDE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15805682 ↗MalfunctionMay 9, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE REAMER AND REAMER COLLET BECAME FUSED TOGETHER WHILE REAMING..
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8595404 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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