ATTUNE 2506-30-210Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM ATTUNE REVISION FEMORAL OFFSET GUIDE RIGHT 2MM · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 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 10603295478577), received between Apr 8, 2020 and Aug 21, 2025 — classified as 3 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
- Material Deformation1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- 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.
MalfunctionAug 21, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT THE 2MM OFFSET INSTRUMENT FOR THE FOUR IN ONE IS JAMMED AND THEY COULD NOT ATTACH THE STEM SPACER. HAD TO CHANGE PLAN AND USE A DIFFERENT OPTION. IT DELAYED THE SURGERY ABOUT 5 MINUTES TO DETERMINE OPTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859821 ↗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 10852954 ↗MalfunctionApr 8, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
ATTUNE REVISION CORE INSTRUMENT SET BOOKED FOR A CASE AT CASTLE HILL HOSPITAL. UNFORTUNATELY DURING SET UP FOR THE CASE THE SCRUB NURSE APPEARS TO HAVE CROSS THREADED TWO INSTRUMENTS TOGETHER (TWICE).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9935655 ↗
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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