ATTUNE 2545-01-036Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL MEDIALIZED ANATOMIC PATELLA TRIAL 32mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295384465), received between Jan 15, 2020 and May 19, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (14 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break14
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT THE POST WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219403 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557909 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557880 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THE DEVICES WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23557743 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555900 ↗MalfunctionNov 14, 2025Break; Break
IT WAS REPORTED THAT THE PRODUCTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555879 ↗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 23537183 ↗MalfunctionAug 1, 2025Break; Break
IT WAS REPORTED THE POST ON THE 32MM ANATOMIC TRIAL BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22687822 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT THE PEG ON THE BOTTOM OF THE PATELLA BUTTON BROKE OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872625 ↗MalfunctionJul 10, 2024Break; Break
IT WAS REPORTED THAT THE TRIALS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 19709153 ↗MalfunctionJun 2, 2021Break; Break
IT WAS REPORTED THAT THE 32 ANATOMIC PATELLA PEG BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11920103 ↗MalfunctionMar 4, 2021Break; Break
IT WAS REPORTED THAT THE SHIMS ARE CRACKED. THE ANATOMICAL PATELLA HAS A PEG THAT HAS SHEARED OFF. THE FIXED BEARING AND RP IMPACTORS ARE CRACKED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11417386 ↗MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED THAT THE PEG BROKE OFF BACK OF PATELLA TRIAL. TWO PIECES AND BOTH PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9643757 ↗MalfunctionJan 15, 2020Break; Break
IT WAS REPORTED THAT THE ATTUNE ANATOMIC PATELLA TRIAL WAS 32 BROKEN ANCHOR PEG. ALL ITEMS WERE SAFELY REMOVED FROM PATIENT. NO ADDITIONAL INFORMATION AVAILABLE. PLEASE SEND REPLACEMENT TO WNC TEAM,SOS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9592698 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page