ATTUNE 2504-40-305Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION FE GUIDE SIZE 5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295438540), received between Sep 14, 2020 and Jun 2, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
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.
Most reported problems
Device problems
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2021Material Twisted/Bent; Material Twisted/Bent
ITEMS DAMAGED: THIS WAS DISCOVERED UPON OPENING THE DEMO SET PRIOR TO TRAINING. THE 4MM OFFSET GUIDE BECAME CROSS THREADED IN ONE OF THE FE GUIDES, THE HEX ATTACHMENT (1.3) WAS BENT AS THIS WAS ATTEMPTED TO BE UNSCREWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11920498 ↗MalfunctionSep 14, 2020Mechanical Jam; Mechanical Jam
F/E GUIDE SIZE 5 WOULD NOT SMOOTHLY ALLOW A PIN TO BE DRILLED THROUGH THE RIGHT DIVERGENT PIN HOLE. THE PIN GOT STUCK AND SNAPPED IN THE HOLE NEEDED TO BE HAMMERED OUT. THE LOCKING LIP WHICH ENGAGES WITH THE FEMORAL BROACH FRACTURE OFF COMPLETELY MAKING THE BROACH UNUSABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10532260 ↗
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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