ATTUNE 2544-00-016Recalls & reported problems
Depuy (Ireland) · ATTUNE SYMMETRICAL CUTTING BLOCK 0 DEGREE · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295421092), received between Dec 15, 2022 and Nov 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (2 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
- Scratched Material2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Material Deformation; Material Deformation
IT WAS REPORTED, THAT THE 3-5 TIBIAL STOP WAS CRACKED. THE 6-8 TIBIAL PUNCH WOULD NO LONGER CONNECT TO HANDLE. AND SYMMETRICAL 0 DEGREE TIBIAL BLOCK WAS SLIGHTLY BENT, NOT ALLOWING FOR PIN PLACEMENT.
Patient problems: Insufficient Information
MAUDE report 20759347 ↗MalfunctionDec 15, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT CUTTING BLOCK WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987323 ↗MalfunctionDec 15, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE CUTTING BLOCK IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987237 ↗
Other INSTRUMENT, CUTTING, ORTHOPEDIC devices
- SIGMA LCS 9505-01-230Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC95 reports
- ATTUNE 2544-00-522Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC58 reports
- SIGMA LCS 9505-01-229Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC56 reports
- SIGMA 2024-40-100Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC43 reports
- ATTUNE 2545-00-158Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- ATTUNE 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 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