ATTUNE 2545-01-039Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL MEDIALIZED ANATOMIC PATELLA TRIAL 41mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295384496), received between Mar 11, 2022 and Nov 14, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556831 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556825 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556772 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556769 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555877 ↗MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS NEED REPLACEMENT. THIS DID NOT HAPPEN IN SURGERY. THERE WAS NO SURGICAL DELAY. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895241 ↗MalfunctionJun 15, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED. ADDITIONAL EVENT INFORMATION: THE VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE ATTUNE CONV MED ANAT PAT 41MM HAS BROKEN FROM ONE OF THE POSTS. THE DEVICE EXHIBITS AN OVERALL WORN APPEARANCE CONSISTENT WITH NORMAL AND REPETITIVE USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19543951 ↗MalfunctionMar 11, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS CONFIRMED THAT THE PEG PART OF PATELLA TRIAL HAS BROKEN. IT WAS FOUND DURING PREPARING FOR NEXT TKA SURGERY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13732575 ↗
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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