ATTUNE 2545-00-155Recalls & reported problems
Depuy (Ireland) · ATTUNE A-P CHAMFER BLOCK SIZE 5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Depuy ATTUNE A-P chamfer block is an orthopedic cutting instrument. Reports mostly describe parts deforming or failing to cut, with some breaking or corroding; patient impact was rarely noted. There are 40 reports, no deaths and no injuries, and no recalls name this device. Reports rose to 13 in the last 12 months from 6 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
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295395287), received between Sep 25, 2019 and Feb 12, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (22 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
- Material Deformation22
- Failure to Cut12
- Naturally Worn4
- Break3
- Corroded3
- Device-Device Incompatibility2
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient11
- Insufficient Information2
- No Code Available2
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
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 24320518 ↗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 24320514 ↗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 24320443 ↗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 24320441 ↗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 24320436 ↗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 24320434 ↗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 HAVE SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320388 ↗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 HAVE SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320387 ↗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 HAVE SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320385 ↗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 HAVE SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320383 ↗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 HAVE SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320381 ↗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 HAVE SEEMED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320377 ↗MalfunctionSep 8, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE PIN HOLES WERE STRIPPED. METAL SHAVINGS BEING PRODUCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992410 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. ATTUNE EM TIBIAL ANKLE CLAMP BLACK PART BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22350292 ↗MalfunctionMay 19, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045872 ↗MalfunctionApr 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT A SIZE 5 AP CHAMFER CUT BLOCK WAS DAMAGED AND NEEDED REPLACING. THE DAMAGE IS AT THE CORNERS OF THE CUT SLOTS THE BLOCK HAS DEVELOPED SHARP EDGES WHICH ARE A RISK TO SURGEON STERILITY DURING THE CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872576 ↗MalfunctionMar 11, 2025Incorrect Measurement; Device-Device Incompatibility; Incorrect Measurement; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS A VERY APPARENT DISCREPANCY BETWEEN THE SIZE 5 CUTTING BLOCK AND THE SIZE 5 TRIAL. STAFF CUT WITH THE SIZE 5 FOUR-IN-ONE BLOCK AND THE SIZE 5 TRIAL WOULD NOT FIT. AFTER CLEANING IT UP WITH FREEHAND CUTS, STAFF WERE ABLE TO GET THE TRIAL TO FIT. BECAUSE THEY WERE PERFORMING A BILATERAL TOTAL KNEE REPLACEMENT, THEY USED THE SAME BLOCK ON THE CONTRA LATERAL SIDE WITH THE SAME RESULT, ALLOWING THEM TO RULE OUT THE POSSIBILITY OF A WARPED/FAULTY FEMORAL TRIAL.
Patient problems: Insufficient Information
MAUDE report 21574974 ↗MalfunctionFeb 7, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CUTTING BLOCK HAS JAGGED EDGES ON THE BACK OF IT. THE PATELLA CLAMP WILL NOT SECURELY ACCEPT ATTACHMENTS. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21337771 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORMATION AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096100 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORRMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096099 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORRMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096095 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096094 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORRMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096088 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19096067 ↗MalfunctionMar 25, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE CHAMFER BLOCK IS DEFORMED. CANNOT GET SAW THROUGH. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18967591 ↗
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 2545-00-157Depuy (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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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