ATTUNE 2545-01-027Recalls & reported problems
Depuy (Ireland) · ATTUNE MEDIAL DOME PATELLA TRIAL 35mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune patella trial is a plastic sizing trial used during knee replacement surgery to check how a replacement kneecap fits before the real implant goes in. The 48 reports mostly describe the trial's small peg or post snapping off, sometimes during the operation and sometimes just from handling, with broken bits sometimes discarded rather than retrieved. No deaths or injuries were reported, 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
- 52
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295136040), received between Feb 8, 2019 and Sep 16, 2026 — classified as 52 malfunctions.
The most frequently reported specific device problem is “Break” (51 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
- Break51
- Crack3
- Component Missing1
- Device-Device Incompatibility1
- Difficult to Advance1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Insufficient Information4
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break
It was reported that the ATTUNE MEDIAL DOME PAT TRL35MM device was broken. It was reported that the device was given back by the sterile processing department. It was reported that there was no injury to the patient or user, and no surgical delay. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793617 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722181 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717837 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555099 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550494 ↗MalfunctionJun 30, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCT HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ATTUNE MEDIAL DOME PAT TRL35MM HAS BROKEN ONE OF THE THREE PRONGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666315 ↗MalfunctionMay 25, 2026Break
IT WAS REPORTED THAT THE PATELLA TRIAL PEG HAD FALLEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25271002 ↗MalfunctionApr 23, 2026Break; Difficult to Advance
IT WAS REPORTED THAT 35 DRILL GUIDE DEVICE GOT BONDED UP IN THE LUG DRILL AND DID NOT SEAT PROPERLY. THE 35 PATELLA TRIAL, THE PLASTIC PEG NUBBIN CHIPPED OFF AND DID NOT SEAT PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971297 ↗MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT THE PATELLA BUTTON POST WAS FOUND BROKEN WHEN STAFF REMOVED IT FROM THE INSTRUMENT TRAY. IT WAS SHIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911544 ↗MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT THE PLASTIC PATELLA TRIAL PEG BROKE OFF AND WAS RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24718885 ↗MalfunctionMar 4, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? THE SMALL BROKEN PIECE WAS THROWN AWAY BY THE SURGICAL STAFF, THE REST OF THE ARTICULATING SURFACE IS BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507916 ↗MalfunctionFeb 20, 2026Break
IT WAS REPORTED THAT 35 DOME PATELLA TRIALS ONE OF THE LUG TRIALS BROKE OFF. NO ADVERSE CONSEQUENCES. NO TIME ADDED. ALL PARTS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400704 ↗MalfunctionFeb 17, 2026Break
IT WAS REPORTED THAT ONE PEG BROKE OFF. THE DEVICE WAS IN TWO PIECES; EVERYTHING WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366912 ↗MalfunctionDec 16, 2025Break; Break
IT WAS REPORTED THAT PEG BROKE OFF PATELLA TRIAL. THERE WAS NO ISSUE AND NO EFFECT ON PATIENT. TIB IMPACTOR BROKE IN HALF. THERE WAS NO ISSUE AND NO EFFECT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821038 ↗MalfunctionDec 8, 2025Break; Break
IT WAS REPORTED THAT PATELLA TRIAL WAS FOUND IN PAN BROKEN AND THE STANDARD GLENOID DRILL IS NO LONGER SHARP ENOUGH TO PERFORM IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23750674 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT ONE OF THE PEGS ON THE 35 DOME PATELLA TRIAL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693519 ↗MalfunctionNov 5, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT 35 DOME PATELLA BUTTON WAS CHIPPED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS CRACKED. ACCORDING TO THE REPORTER, PART OF THE PLASTIC WAS WORN AWAY FROM THE TOP OF THE PATELLA BUTTON MAKING THE SURFACE NO LONGER SMOOTH; A CHUNK WAS MISSING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476157 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT THE LITTLE PEG ON PATELLA BUTTON BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390702 ↗MalfunctionAug 11, 2025Break; Break
IT WAS REPORTED THAT POST ON THE PATELLA TRIAL BROKE OFF. ALL PIECES WERE RECEIVED. IT DID NOT DELAY THE CASE OR HAVE AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770155 ↗MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE PATELLA TRIAL HAS SNAPPED OFF. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004343 ↗MalfunctionApr 30, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA TRIAL POST BROKE OFF. ALL PIECES WERE REMOVED. TIBIAL IMPACTOR HAD CRACK, NO PIECES BROKEN OFF. THERE WERE NO PIECES LEFT BEHIND IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938437 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT THE 35MM PATELLA TRIAL BROKE DURING SURGERY. ONE OF THE PEGS BROKE OFF THE TRIAL IMPLANT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772180 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT THE PATELLA TRIAL CAME OUT OF WASHER WITH A BROKEN PEG.
Patient problems: Insufficient Information
MAUDE report 21690177 ↗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 21514943 ↗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 21514890 ↗
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
- 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 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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