ATTUNE 2545-01-037Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL MEDIALIZED ANATOMIC PATELLA TRIAL 35mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295384472), received between Oct 21, 2019 and Feb 12, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Break” (12 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
- Break12
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT THE PEG FROM THE 35MM ANATOMIC PATELLA TRIAL BROKE OFF IN THE PREPARED HOLE. IT WAS REPORTED THAT THE PEG WAS SAFELY REMOVED WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321545 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557983 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557844 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557774 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557704 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555881 ↗MalfunctionNov 12, 2025Break; Break
IT WAS REPORTED THAT THE POST WAS BROKEN ON THE PROTHESIS TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23537285 ↗MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED THAT THE TRIALS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 19709147 ↗MalfunctionApr 13, 2023Break; Break
IT WAS REPORTED THAT THE THE PEG BROKE OFF OF 3S ANATOMIC PATELLA TRIAL. AND THE LINER EXTRACTOR IS BENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16731779 ↗MalfunctionApr 14, 2022Break; Break
IT WAS REPORTED THAT ONE OF THE THREE PEGS ON BACK OF PATELLA TRIAL BROKE OFF. IT WAS DISCARDED BY HOSPITAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111816 ↗MalfunctionMar 8, 2022Break; Break
THE PATELLA TRIAL WAS BROKEN. TECH THREW PIECES AWAY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691169 ↗MalfunctionOct 21, 2019Break; Break
IT WAS REPORTED THAT THE 32 PATELLA TRIAL ONE PEG WAS BROKEN OFF, 2 PIECES, ALL RECOVERED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9215004 ↗
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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