ATTUNE 2545-01-028Recalls & reported problems
Depuy (Ireland) · ATTUNE MEDIAL DOME PATELLA TRIAL 38mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE medial dome patella trial is a temporary sizing trial used during knee replacement surgery. Most of the 70 reports describe the trial breaking during use, with the small peg shearing off or the piece snapping in two, sometimes with the coating coming off; fragments were retrieved in the cases described. There are 12 reports in the last 12 months and 14 in the prior 12 months, with no deaths or injuries 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
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10603295136057), received between Sep 25, 2017 and Sep 18, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Break” (66 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
- Break66
- Material Twisted/Bent2
- No Apparent Adverse Event2
- Scratched Material2
- Component Missing1
- Crack1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Consequences Or Impact To Patient10
- Insufficient Information9
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820923 ↗MalfunctionApr 17, 2026Break
IT WAS REPORTED AN ATTUNE TRIAL PATELLA BROKE WHILE IN USE. ALL PARTS WERE RETRIEVED; SURGERY TIME WAS NOT EXTENDED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911393 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT THE 38 MM DOME ATTUNE PATELLA TRIAL PEG BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846757 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THE COATING WAS COMING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494737 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT THE PATELLA WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430031 ↗MalfunctionFeb 20, 2026Break
IT WAS REPORTED THAT, UPON INSERTION, IT WAS OBSERVED THAT THE PEG BROKE OFF THE PATELLA TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404091 ↗MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT THE PEG ON THE PATELLA TRIAL WAS BROKEN. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE INTO 2 PIECES AND THE PIECES WERE RETRIEVED AND DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24282911 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT THE PEG SHEARED OFF PATELLA TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251530 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT PEG WAS BROKEN ON THE PATELLA TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066979 ↗MalfunctionDec 29, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905997 ↗MalfunctionDec 9, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE DOME PATELLA WAS BROKEN. IT WAS REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761379 ↗MalfunctionNov 13, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT IT BROKE INTO 2 PIECES. PEG BROKE OFF REST OF THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23540674 ↗MalfunctionNov 7, 2025Break; Break
IT WAS REPORTED THAT THE PEG BROKE OFF THE PATELLA TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498998 ↗MalfunctionSep 19, 2025Break; Break
IT WAS REPORTED THAT DURING A PRIMARY TKA, THE SURGEON SHOWED THAT ONE OF THE PLASTIC PEGS FROM THE 38 DOME PATELLA TRIAL HAD BROKEN OFF. THE PIECE WAS RETRIEVED AND THROWN AWAY. THERE WERE NO DELAYS OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096258 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22796789 ↗MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THAT A PEG ON THE PATELLA TRIAL IS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726681 ↗MalfunctionMay 14, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT BEFORE SURGERY STARTED OR STAFF NOTICED ONE OF THE BUTTONS OF PATELLA TRIAL HAD STARTED TO CRACK. ALL PIECES WERE REMOVED FROM FIELD. THE BUTTON WAS NOTED AS BROKEN IN 2 PIECES. NO PATIENT CONSEQUENCES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22019065 ↗MalfunctionApr 24, 2025Break; Break
IT WAS REPORTED THE DOME PATELLA TRIAL BUTTON BROKE. THE PEG BROKE OFF OF THE BOTTOM. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902533 ↗MalfunctionApr 21, 2025Break; Break
IT WAS REPORTED THAT ONE PEG IS MISSING AND REQUEST TO REPLACE 38 PATELLA TRIAL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21874117 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT ONE LEG FEEL OFF OF THE 38MM PATELLA TRIAL. THEY FOUND TO BE OFF BEFORE IMPACTION/PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710848 ↗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 21515055 ↗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 21515020 ↗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 21514933 ↗MalfunctionFeb 24, 2025Break; Break
IT WAS REPORTED THERE WAS A MISSING PEG ON PLASTIC PATELLA TRIAL.
Patient problems: Insufficient Information
MAUDE report 21446702 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT THE 38 PATELLA TRIAL PEG WAS BROKEN. ONLY ONE OF THE PEGS BROKE OFF, AND IT WAS REMOVED FROM THE TABLE.
Patient problems: Insufficient Information
MAUDE report 21412696 ↗
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 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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