ATTUNE 2545-01-029Recalls & reported problems
Depuy (Ireland) · ATTUNE MEDIAL DOME PATELLA TRIAL 41mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy Attune domed patella trial, a temporary sizing template used during knee replacement surgery. The 32 reports describe trial components breaking, chipping or cracking — sometimes a peg snapping off during removal — along with a few scratched or bent parts. Most were found during routine tray inspections at hospitals rather than during surgery, and no patient harm was described. There are no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295136064), received between Jan 5, 2021 and May 13, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Break” (31 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
- Break31
- Material Twisted/Bent2
- Scratched Material2
- Crack1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT REPORTED THAT THE 41MM PATELLA TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159884 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT WHEN REMOVING THE PATELLA TRIAL COMPONENT, ONE OF THE PEGS BROKE OFF AND FELL ON THE FLOOR. NO PART OF THE TRIAL FELL OFF IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752388 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT THE 41 DOMED PATELLA TRIAL/LEG WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616631 ↗MalfunctionFeb 13, 2026Break
254501029 - EDGE CHIPPED AND OUT OF SHAPE THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332442 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT DURING ROUTINE INSPECTIONS OF ATTUNE INSTRUMENT CONSIGNMENT TRAYS AT THE HOSPITAL, EIGHT ATTUNE INSTRUMENTS WERE FOUND TO BE DAMAGED. FIVE SHIMS WERE FOUND TO BE CRACKED, WITH CRACKS EXTENDING FROM THE METAL DRILL GUIDES TO THE OUTER OR INNER EDGE OF EACH SHIM. ALSO, AN ATTUNE SPACER BLOCK WAS FOUND TO BE MISSING TWO OF ITS FOUR BAL SEAL SPRINGS AND A PATELLA TRIAL WAS FOUND TO BE MISSING ONE OF ITS THREE LUGS, FINALLY, A CR FEMUR TRIAL HAS A TRANSVERSE CUT LINE ACROSS ITS DISTAL CONDYLES, LIKELY CAUSED BY A SAGITTAL SAW. IT IS UNKNOWN WHEN, WHERE, OR HOW THE INSTRUMENTS WERE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851378 ↗MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THAT TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23749083 ↗MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THAT TRIAL WAS CHIPPED ON THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23748831 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT ONE OF THE PEGS FROM PATELLA TRIAL BROKE OFF OF TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584136 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT THE 41MM DOME PATELLA TRIAL PEG SNAPPED OFF. FRAGMENT WAS RETRIEVED. THERE WAS NO TIME ADDED TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337584 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA TRIAL PEG BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22117495 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT TRIAL BROKE ON EXTRACTION. BROKE INTO 2 PIECES. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997310 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT PEG ON TRIAL WAS CHIPPED. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21877980 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515091 ↗MalfunctionMar 4, 2025Break; Break
IT WAS REPORTED THAT THE DEVICES WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515081 ↗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 20895583 ↗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 20895191 ↗MalfunctionOct 24, 2024Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENTS AND TRIALS ARE WORN. RP TIBIA IMPACTOR IS CRACKED AND 41MM PATEL TRIAL HAS BROKEN POST. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20521294 ↗MalfunctionSep 23, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE PATELLA TRIAL WAS CRACKED AND CHIPPED AND THE SURGEON WOULD LIKE IT REPLACED.
Patient problems: Insufficient Information
MAUDE report 20277659 ↗MalfunctionAug 9, 2024Break; Break
IT WAS REPORTED THAT PEG ON PATELLA TRIAL BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 19948394 ↗MalfunctionJun 24, 2024Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT THE SPD SAID IT NEEDED TO BE REPLACED DUE TO WEAR AND SCRATCHES.
Patient problems: Insufficient Information
MAUDE report 19593959 ↗MalfunctionMar 14, 2024Break; Break
IT WAS REPORTED THAT THE PATELLA PEG ON TRIAL IS BROKEN OFF.
Patient problems: Insufficient Information
MAUDE report 18901843 ↗MalfunctionFeb 9, 2024Break; Break
IT WAS REPORTED THAT THERE IS A BROKEN/CHIPPED PEG ON THE 41 MM OVAL DOME PATELLA TRIAL AND CHIPPED SHIM SIZE 9/10 - 5MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18675693 ↗MalfunctionDec 4, 2023Break; Break
IT WAS REPORTED THAT THE 41 PATELLA PEG BROKE. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18263716 ↗MalfunctionAug 30, 2023Break; Break
IT WAS REPORTED THAT THE PATELLA PEG BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650496 ↗MalfunctionAug 16, 2023Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE PATELLA TRIAL HAD CUTS AND CHIPPED FROM A SAW BLADE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557808 ↗
Other TEMPLATE devices
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- 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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