ATTUNE 2545-01-035Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL MEDIALIZED ANATOMIC PATELLA TRIAL 29mm · 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 10603295384458), received between Apr 22, 2024 and Feb 3, 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 Conditions9
- Insufficient Information3
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT THE PATELLA TRIAL 41MM HAS A POST SHEARED OFF, IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250936 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555903 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555894 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555890 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555887 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555884 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT THE POST ON THE TRIAL BROKE OFF DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390780 ↗MalfunctionAug 15, 2025Break; Break
IT WAS REPORTED THAT POST BROKE DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22814432 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT THE PEG BROKE ON A TRIAL PATELLA. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21414768 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT POST BROKE OFF ON TRIAL PATELLA. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056817 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE TRIAL WAS BROKEN. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19700465 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THAT 29MM ANATOMIC PATELLA TRIAL PEG BROKE.
Patient problems: Insufficient Information
MAUDE report 19151788 ↗
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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