ATTUNE 2506-10-007Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FB BASE TRIAL SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295435907), received between Dec 20, 2017 and Aug 29, 2025 — classified as 4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Break1
- Disassembly1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A WORKSHOP, IT WAS NOT POSSIBLE TO PROPERLY FIX THE THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. IT SEEMS THAT SOMETHING IS WRONG WITH THE TREADS OF THE TRIAL. THEY ARE SOMEHOW COLD WELDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922077 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THAT THE HEAD OF THE TRIAL SCREW THAT MATES UP WITH THE EXTENSION BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 21218326 ↗MalfunctionDec 1, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WHEN SETTING THE INSTRUMENT FOR A CASE IT WAS DISCOVERED THAT THE THREADS ON BOTH TIBIAL TRIAL AND THE WEDGE WERE STRIPPED AND WOULD NOT ALLOW THE WEDGE TO BE ATTACHED TO THE TIBIAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10929787 ↗MalfunctionDec 20, 2017Disassembly; Disassembly
IT WAS REPORTED THAT THE LOCKING RING AND BOLT CAME OUT OF REVISION TIBIA TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7133590 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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