ATTUNE 2504-40-100Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION BOSS ADAPTOR TRIAL · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 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 10603295439639), received between Apr 3, 2019 and Jul 3, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (4 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
- Material Deformation4
- Device-Device Incompatibility2
- Material Twisted/Bent1
- Naturally Worn1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- 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.
MalfunctionJul 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOSS ADAPTOR CROSS THREADED STEMS NO LONGER THREAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398573 ↗MalfunctionJan 8, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOSS ADAPTOR TRIALS WERE CROSS THREADED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21103906 ↗MalfunctionJan 8, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOSS ADAPTOR TRIALS WERE CROSS THREADED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21103877 ↗MalfunctionMay 3, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT BOSS ADAPTOR WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 19237155 ↗MalfunctionApr 13, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE BOSS TRIAL THREADS BENT, NO LONGER ACCEPT STEM TRIAL BUSHING HAS METAL SPUR AND DOES NOT ALLOW REAMER TO SPIN PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11656415 ↗MalfunctionOct 16, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE TWO PIECES CROSS THREADED BECAME STUCK TOGETHER IN A SURGERY ON (B)(6) 2020.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10690810 ↗MalfunctionApr 3, 2019No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING SAW BONES WORKSHOP TRAINING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8480275 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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