ATTUNE 2545-01-038Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL MEDIALIZED ANATOMIC PATELLA TRIAL 38mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295384489), received between May 8, 2018 and Nov 14, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Cut In Material1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 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 23558066 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23558065 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23558028 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556751 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555878 ↗MalfunctionSep 10, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018886 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THE PEG BROKE OFF DURING TRIALING. ALL PARTS WERE REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340472 ↗MalfunctionMay 20, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN ATTUNE PATELLA TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354308 ↗MalfunctionJul 21, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE ITEMS WERE DAMAGED THROUGH WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17370336 ↗MalfunctionMay 8, 2018Cut In Material; Material Deformation; Cut In Material; Material Deformation
IT WAS REPORTED THAT THE OFFICE SET IS GOUGED. DID NOT EFFECT SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7494455 ↗
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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