ATTUNE 2545-00-154Recalls & reported problems
Depuy (Ireland) · ATTUNE A-P CHAMFER BLOCK SIZE 4 · 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 a size 4 cutting block used to shape bone during hip replacement surgery. The 28 reports mostly describe the metal block deforming, wearing down, or developing sharp edges and cracks, with a few cases of corrosion and blocks not fitting other instruments; several were found during routine sterilization checks rather than during surgery. No deaths or injuries were reported, and there are no recalls for this device.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295395270), received between Aug 28, 2018 and Jun 30, 2025 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (19 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 Deformation19
- Naturally Worn4
- Corroded3
- Device-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Crack1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient11
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357526 ↗MalfunctionOct 28, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BLOCK HAS SHARP EDGES. SURGEON WANTED IT REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20544240 ↗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 19096259 ↗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 19095790 ↗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 19095789 ↗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 19095787 ↗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 19095786 ↗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 19095785 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023, THE PRODUCTS IN QUESTION WERE USED IN THE SURGERY VIA TKA FOR OA. IN THE SURGERY, WHEN THE OSTEOTOMY WAS PERFORMED, THE SAID SAW CAPTURE WAS ATTACHED TO THE SAID CUTTING BLOCK OF SIZE4, BUT IT FELL OFF. IT WAS CONFIRMED THAT THEY DID NOT LOCK. THEREFORE, THE SURGEON USED A MUSCLE HOOK TO PERFORM THE OSTEOTOMY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17612131 ↗MalfunctionJun 21, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SHARP EDGES GENERATED FROM SAW BLADE WAS UNSAFE FOR USE.
Patient problems: Insufficient Information
MAUDE report 17173060 ↗MalfunctionMar 15, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INSTRUMENTS WERE DISCOVERED AS DAMAGED, CRACKED, MISSING SPRINGS AND A METAL BURR IN THE CUTTING BLOCK SAW CAPTURE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13769066 ↗MalfunctionMar 15, 2022Material Deformation; Material Deformation
THE INSTRUMENTS ARE DAMAGED CRACKED, MISSING SPRINGS AND THERE IS A METAL BURR IN THE CUTTING BLOCK SAW CAPTURE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13765493 ↗MalfunctionFeb 1, 2022Device-Device Incompatibility; Device-Device Incompatibility
AFTER USING TWO HEADED PINS TO MAKE THE 4IN1 CUTS, THE ASSISTANT USED A PIN DRIVER TO REMOVE THE PIN AND IT WOULD NOT COME OUT. ATTEMPTED TO USE THE ATTUNE PIN ADAPTOR ON A HUDSON BUT IT DID NOT WORK. THE CUTTING BLOCK WAS ABLE TO GET OFF BUT UNABLE TO REMOVE THE SCREW DUE TO IT BEING BENT. WORKED WITH THE SCRUB IN THE CASE AND SPD AFTERWARDS BUT WAS NOT ABLE TO REMOVE IT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13419697 ↗MalfunctionSep 30, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CUTTING BLOCKS HAVE BEEN WORN OVER TIME BY THE SAW BLADE, MAKING THEM DIFFICULT TO USE FOR THE SURGEON IN THE CASE. HE HAS REQUESTED NEW BLOCKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12553976 ↗MalfunctionSep 29, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE CUTTING BLOCKS HAVE BEEN WORN OVER TIME BY THE SAW BLADE, MAKING THEM DIFFICULT TO USE FOR THE SURGEON IN THE CASE. HE HAS REQUESTED NEW BLOCKS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12550004 ↗MalfunctionMay 26, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR LEFT OA. DURING THE SURGERY, WHEN THE SURGEON PERFORMED AN OSTEOTOMY WITH THE INSTRUMENTS, A LARGE AMOUNT OF METAL DEBRIS WAS GENERATED, AND THE BONE STAINED BLACK. THE SURGEON SUSPECTED THAT THE MATERIAL HAD CHANGED AND COMMENTED THAT THE MATERIAL OF THE INSTRUMENTS HAD BECOME LESS EXPENSIVE. WHEN AN OSTEOTOMY WAS PERFORMED WITH A NOTCH GUIDE, AN OSTEOTOMY WAS PERFORMED WITH A RECIPROCATING SAW, BUT THE METAL PART WAS SEVERELY ABRADED. ALSO, THE PRECISION OF THE SLIT SEEMED TO BE POOR, AND A LARGE AMOUNT OF METAL DEBRIS WAS GENERATED. THE SURGEON USED A 1.19 MM BLADE. THE CLEARANCE WITH THE SLIT WAS LARGE, AND THE SURGEON ALSO OPERATED NOT TO TOUCH THE SLIT. THE SURGEON STATED THAT EVEN A NEW INSTRUMENT DID NOT DO THIS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11890297 ↗MalfunctionMar 24, 2020Corroded; Material Deformation; Corroded; Material Deformation
THE PROBLEM WAS THAT THE METAL QUALITY WAS INFERIOR AND THIS LEADS TO SHARP METAL EDGES IN THE CUTTING SLOTS AND EVEN RUST/CORROSION FORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9874485 ↗MalfunctionMar 24, 2020Corroded; Material Deformation; Corroded; Material Deformation
THE PROBLEM WAS THAT THE METAL QUALITY WAS INFERIOR AND THIS LEADS TO SHARP METAL EDGES IN THE CUTTING SLOTS AND EVEN RUST/CORROSION FORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9874477 ↗MalfunctionMar 24, 2020Corroded; Material Deformation; Corroded; Material Deformation
THE PROBLEM WAS THAT THE METAL QUALITY WAS INFERIOR AND THIS LEADS TO SHARP METAL EDGES IN THE CUTTING SLOTS AND EVEN RUST/CORROSION FORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9871177 ↗MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionOct 24, 2019Material Deformation; Material Deformation
MalfunctionSep 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE 4 IN 1 BLOCKS WERE FRAYED ON EDGES WERE TEARING GLOVES. NEED TO BE DULLED DOWN OR REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119229 ↗MalfunctionSep 25, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE 4 IN 1 BLOCKS WERE FRAYED ON EDGES WERE TEARING GLOVES. NEED TO BE DULLED DOWN OR REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119221 ↗
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.
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