ATTUNE 2545-00-158Recalls & reported problems
Depuy (Ireland) · ATTUNE A-P CHAMFER BLOCK SIZE 8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE A-P chamfer block is an orthopedic cutting instrument. The 41 reports on file describe malfunctions such as cuts seeming off, often with aging blocks, plus material deformation, corrosion and mechanical jamming; there were no deaths or injuries. No recalls name this device. Reports rose sharply to 24 in the last 12 months, up from 3 the year before.
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
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295395317), received between Jun 6, 2019 and Feb 20, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (24 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
- Failure to Cut24
- Material Deformation9
- Corroded3
- Break2
- Device-Device Incompatibility2
- Mechanical Jam2
- Naturally Worn2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient8
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Failure to Cut
IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399487 ↗MalfunctionFeb 20, 2026Failure to Cut
IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399480 ↗MalfunctionFeb 20, 2026Failure to Cut
IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399479 ↗MalfunctionFeb 20, 2026Failure to Cut
IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399476 ↗MalfunctionFeb 20, 2026Failure to Cut
IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399468 ↗MalfunctionFeb 20, 2026Failure to Cut
IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399439 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT FACILITY'S CUT BLOCKS WERE 10+ YEARS OLD. NEED TO BE REPLACED AS THEY HAVE HAD 2+ CASES WHERE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368778 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT FACILITY'S CUT BLOCKS WERE 10+ YEARS OLD. NEED TO BE REPLACED AS THEY HAVE HAD 2+ CASES WHERE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368765 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367087 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367079 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367077 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367074 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366820 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366817 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363490 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363488 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363487 ↗MalfunctionFeb 17, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363484 ↗MalfunctionFeb 12, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320513 ↗MalfunctionFeb 12, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320511 ↗MalfunctionFeb 12, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320510 ↗MalfunctionFeb 12, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320508 ↗MalfunctionFeb 12, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320507 ↗MalfunctionFeb 12, 2026Failure to Cut
IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320440 ↗MalfunctionJul 8, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE BLOCK DAMAGED DUE TO WEAR AND TEAR, CAUSING THREADED PIN TO GET STUCK IN BLOCK. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437061 ↗
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 2545-00-156Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC41 reports
- SIGMA 2024-40-200Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC40 reports
- ATTUNE 2545-00-155Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC39 reports
- ATTUNE 2545-00-157Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC37 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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