ATTUNE 2545-01-049Recalls & reported problems
Depuy (Ireland) · ATTUNE MEDIALIZED DOME PATELLA DRILL TRIAL 32mm · 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 10603295395522), received between Aug 17, 2021 and Dec 10, 2025 — classified as 5 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
- Break1
- Crack1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL TRIAL WILL NO LONGER FIT THE CLAMP HANDLE BUT THE OTHER ONES DO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23770930 ↗MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PATELLA DRILL GUIDE WOULD NOT STAY ON THE CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760639 ↗MalfunctionJun 2, 2025Crack; Material Deformation; Crack; Material Deformation
IT WAS REPORTED THAT SPD NOTIFIED OF THE INSTRUMENTS DEEMED TO BE DAMAGED AND NOT FIT TO BE RESTERILIZED DUE TO CRACKS. PATELLA WAS SCARRED AS IF IT HAD BEEN HIT WITH A SAW BLADE. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122777 ↗MalfunctionOct 26, 2021Break; Break
IT WAS REPORTED THAT THE PATELLA DRILL TRIALS SPIKES ARE MISSING. RECEIVED TRAY WITH PATELLA TRIALS MISSING THE SPIKES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12700568 ↗MalfunctionAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE PATELLA DRILL CLAMP WILL NOT CORRECTLY ATTACH TO THE MODULAR PATELLA DRILL TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12331667 ↗
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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