ATTUNE 2546-00-002Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION 6MM HEX DRIVER · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295477877), received between Feb 25, 2020 and Jul 3, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Naturally Worn2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2025Break; Break
IT WAS REPORTED THAT THE REAMER AND SCREWDRIVER ARE BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396388 ↗MalfunctionJul 24, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817160 ↗MalfunctionJan 10, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT END OF THE INSTRUMENT IS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16132421 ↗MalfunctionDec 13, 2021Naturally Worn; Naturally Worn
DRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12984938 ↗MalfunctionFeb 25, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE 6MM HEX DRIVER IS STRIPPED. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9750208 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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