ATTUNE 2506-30-209Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FEMORAL IM ADAPTOR · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295489801), received between Sep 19, 2018 and Nov 12, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Break2
- Dull, Blunt1
- Material Deformation1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE THREADS ON THE FEMORAL IM ADAPTOR FOR ATTUNE REVISION APPEARED TO BE CROSS-THREADED AND THE STEM WOULDN¿T CONNECT TO THE BACK OF IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536573 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAS A BROKEN THREAD AND CAN NO LONGER BE USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480089 ↗MalfunctionJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A REVISION CASE, THE FEMORAL IM ADAPTOR WOULD NOT CONNECT TO ANY OF THE STEM STABILISERS. THERE WAS A DELAY IN THE SURGERY AS THE SURGEON HAD TO FOLLOW A DIFFERENT WORK FLOW, WHICH DELAYED THE SURGERY BY 2 HOURS.
Patient problems: Insufficient Information
MAUDE report 21072952 ↗MalfunctionAug 25, 2022Break; Break
SCREW CAME OUT OF THE INSTRUMENT WHEN DISASSEMBLING THE CUTTING JIG. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15293669 ↗MalfunctionNov 17, 2020Device-Device Incompatibility; Device-Device Incompatibility
THE 2 INSTRUMENTS APPEARED TO BE FUSED AND AS SUCH WE COULD NOT ATTACH THE REQUIRED STABILIZERS TO PERFORM THE REQUIRED STEP OF THE PROCEDURE.
Patient problems: No Code Available
MAUDE report 10852947 ↗MalfunctionOct 15, 2020Mechanical Jam; Mechanical Jam
DURING A WORKSHOP THE TIP OF THE INSTRUMENT WAS FOUND TO BE JAMMED. NO PATIENT CONSEQUENCES, NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10687121 ↗MalfunctionSep 19, 2018Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE ONE SIDE OF INSTRUMENT, THE SCREW IS STRIPPED AND WILL NOT SEAT ALL THE WAY DOWN. NEED NEW ONE ASAP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7888910 ↗
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- 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.
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