ATTUNE 2545-01-026Recalls & reported problems
Depuy (Ireland) · ATTUNE MEDIAL DOME PATELLA TRIAL 32mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 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 10603295136033), received between Oct 11, 2017 and Jun 25, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information2
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE PATELLA TRIAL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25624996 ↗MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT PEG ON THE PATELLA TRIAL WAS BROKEN. THERE WAS TWO PIECES. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25484646 ↗MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT ONE OF THE STUBS BROKE OFF THE 32 PATELLA DOME TRIAL AND WAS RETRIEVED FROM THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911656 ↗MalfunctionMar 19, 2026Break
THIS INSTRUMENT WAS FOUND TO HAVE SLIGHT CHIPPING AT ONE OF THE PEGS OF THE SIZE 32 PATELLA TRIAL. OTHER PEGS INTACT. FOUND PRE-OPERATIVELY AS THE SCRUB NURSE WAS OPENING THE TRAY; WAS NOT USED ON THE PATIENT. UNFIXABLE INSTRUMENT. KIT HAS BEEN AROUND FOR A WHILE, USUAL WEAR AND TEAR. NO ADVERSE EFFECT TO PATIENT; DELAYED SURGERY TIME BY TWO MINUTES WHILE A NEW TRAY WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641557 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT THE FULL 32 DOME PATELLA PEG BROKE, AND THE TIBIAL ALIGNMENT HANDLE AND THE INSPECTION HANDLE ALSO BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201183 ↗MalfunctionJan 23, 2026Scratched Material
IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE SCREWDRIVER HANDLE HAD SOMETHING STUCK IN THE CANNULATED HOLE AND RP PS ARTIC SURFACE HAD A BROKEN PEG. NOTHING FURTHER TO REPORT. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161087 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT ONE OF THE PEGS ON THE 32 DOME PATELLA TRIAL BROKE(SNAPPED) OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831786 ↗MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED THAT A STUB OF THE 32 PATELLA TRIAL BROKE WHILE TRAILING AND EVERY PIECE WAS RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687712 ↗MalfunctionApr 1, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR SPLIT IN HALF WHILE IMPACTING PRESS FIT TIBIA. ALL PARTS WERE RECOVERED AND IT DID NOT IMPACT THE TIMING OF THE CASE OR THE PATIENT. PATELLA PEG BROKE OFF WHILE REMOVING TRIAL. ALL PIECES WERE RECOVERED AND IT DID NOT IMPACT THE TIME OF THE CASE OR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21745226 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED ON (B)(6) 2024 DURING A TOTAL KNEE REPLACEMENT THAT THE LUG DRILL WAS DULL AND WAS NOT CREATING THE CORRECT SIZE LUGS. USERS BROKE A PATELLA TRIAL WHEN TRYING TO SQUEEZE IT IN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20438460 ↗MalfunctionApr 10, 2024Break; Break
THERE WERE NO PATIENT CONSEQUENCES OCCURRED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19078181 ↗MalfunctionAug 25, 2023Break; Break
IT WAS REPORTED THAT ONE OF THE PEGS BROKE ON THE TRIAL AND THE RUBBER PATELLA CLAMP WOULD NOT STAY IN THE METAL BACKING. A TEAR WAS DISCOVERED AT THE PEG PART OF THE RUBBER CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17623867 ↗MalfunctionMar 6, 2023Break; Break
IT WAS REPORTED THAT THE PEG ON THE TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16488058 ↗MalfunctionOct 11, 2017Break; Break
IT WAS REPORTED THAT PEG SHEERED OFF OF PATELLA TRIAL.
Patient problems: No Information
MAUDE report 6942185 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page