ATTUNE 2545-06-003Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL TOWER LEFT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295496977), received between May 13, 2024 and Aug 28, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Calibration Problem1
- Device-Device Incompatibility1
- Mechanical Jam1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Break; Break
IT WAS REPORTED THAT 25MM DRILL WAS BROKEN AND DEPTH GAUGE WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22917731 ↗MalfunctionAug 28, 2025Calibration Problem; Calibration Problem
IT WAS REPORTED FROM THE SURGEONS THAT THE CALIBRATION IS OFF ON ALL OF THESE ITEMS. THE MALFUNCTION DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22917439 ↗MalfunctionJun 6, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT PIECE WAS NOT CATCHING ON THE GROOVES, IT JUST CONTINUES TO MOVE FREELY AND WILL NOT GRASP AT A DETERMINED THICKNESS. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22158537 ↗MalfunctionMay 13, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE TIBIAL TOWER SEEMS TO NOT BE CLICKING AND RELEASING PROPERLY. IT MIGHT BE A SPRING ISSUE. NOTHING FURTHER TO REPORT.
Patient problems: Insufficient Information
MAUDE report 19297448 ↗
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