ATTUNE 2504-40-607Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CONVENTIONAL CUT GUIDE SIZE 7 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy ATTUNE size 7 cut guide block used to shape bone during knee revision surgery. The 30 reports mostly describe the metal cutting block arriving bent, twisted or broken — often spotted when the instrument tray was opened or while the saw blade would not pass through the slot, sometimes forcing the surgeon to open a second set. No deaths or injuries were reported, and no recalls name 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295438465), received between Aug 13, 2018 and Jul 10, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (14 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
- Material Deformation14
- Material Twisted/Bent11
- Device-Device Incompatibility7
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient10
- Not Applicable3
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT CUTTING BLOCK BENT. IT WAS NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469758 ↗MalfunctionMay 19, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT DEVICES ARE FOUND BROKEN OR DAMAGED AFTER ROUTINE TRAY INSPECTION. SIZE 7 CUT BLOCK FROM CONVENTIONAL AND OFFSET ATTUNE REVISION TRAY IS BENT. THE HUMERAL TRIAL ADAPTOR HAS A BROKEN RIM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22046544 ↗MalfunctionMar 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSERT TRIAL HANDLE WAS BENT AND THE SAW BLADE WAS BINDING UP WHILE MAKING POSTERIOR CHAMFER CUT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21626034 ↗MalfunctionOct 23, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT WHILE PERFORMING A REV LTK, THE DOCTOR NOTICED THE ATTUNE SO 7 A/P CUTTING BLOCK WAS BENT POSTERIORLY THRU THE CUTTING SLOTS. THEY OPENED A SECOND SET AND THE CASE PROCEEDED WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517364 ↗MalfunctionJul 22, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE REVISION CUTTING BLOCK WAS BENT.
Patient problems: Insufficient Information
MAUDE report 19792946 ↗MalfunctionJan 18, 2024Material Deformation; Material Deformation
SIZE 7 ATTUNE REVISION CONVENTIONAL CUT BLOCK WAS BENT/DAMAGED WHEN TRAYS WERE OPENED AT THE START OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18540178 ↗MalfunctionJun 26, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE SAW BLADE WOULD NOT FIT THROUGH THE CHAMFERS SAW SLOT OF THE CONVENTIONAL CUTTING GUIDE BLOCK SIZE 7 DUE TO THE BLOCK APPEARING TO BE BOWED OR BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17199341 ↗MalfunctionJun 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE CUT BLOCK WAS JUMPING ON HIS POSTERIOR CHAMFER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17187707 ↗MalfunctionJun 13, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SIZE 7 ATTUNE REVISION CUTTING BLOCK IS BENT AND NEEDS REPLACING. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17117386 ↗MalfunctionApr 25, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CUTTING BLOCK IS BENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16811068 ↗MalfunctionDec 27, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THREADED PIN STUCK IN SIZE 7 CONVENTIONAL CUT BLOCK. NO DELAY OR ISSUE WITH CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16051814 ↗MalfunctionOct 11, 2022Material Deformation; Material Deformation
IT WAS REPORTED CUTTING GUIDE IS BENT AND SLOTS ARE TOO NARROW FOR THE SAW BLADE. HERE WAS NO REPORTED SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579534 ↗MalfunctionApr 28, 2022Material Deformation; Material Deformation
THE SAW BLADE WOULD NOT FIT THROUGH THE POSTERIOR CHAMFER CUTTING BLOCK SLOT. THE BLOCK APPEARS BENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14237713 ↗MalfunctionApr 11, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SAW CAPTURE IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074126 ↗MalfunctionApr 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
THE BOX CUTTING BLOCK WOULDN¿T ENGAGE ONTO 3/1 CUT BLOCK. SURGICAL DELAY OF 5 MINUTES OCCURRED. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14013793 ↗MalfunctionSep 21, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BLOCK HAD BENT IN THE POSTERIOR CHAMFER CUTTING SLOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12510910 ↗MalfunctionMay 27, 2020Material Twisted/Bent; Material Twisted/Bent
250440607 ATTUNE REV CONV CUT GUIDE SZ 7 HAS BENT AT ONE OF THE CUTTING SLOT AREA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10092476 ↗MalfunctionMar 26, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE CUTTING BLOCK WAS BENT WHILE FLEXING THE KNEE. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9886090 ↗MalfunctionFeb 10, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT HAD A LOOSE TIBIA FROM COMPANY CONFORMIST. TIBIA WAS LOOSE AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT MANUFACTURER WAS USED. SURGEON REVISED THE ENTIRE PREVIOUS KNEE REPLACEMENT TO ATTUNE REVISION KNEE SYSTEM. THE SIZE 7, 3 IN 1 CUTTING BLOCK FROM THE CONVENTIONAL & OFFSET FEMUR PAN WAS BENT. THIS HINDERED US TO CUT THE POSTERIOR CHAMFER DUE TO NOT GETTING A SAW BLADE THROUGH IT. SURGICAL DELAY OF 5 MINUTES.
Patient problems: Not Applicable
MAUDE report 9686435 ↗MalfunctionMay 21, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT WHEN CUTTING THE POSTERIOR CHAMBER, THEY SAW BLADE WOULD NOT GO THROUGH. IT DID GO THROUGH NORMALLY ON ALL THE OTHER SLOTS. IT WAS APPARENT THAT THE CUTTING BLOCK WAS BENT WHICH WAS PINCHING OFF THE SAW SLOT. WE ENDED UP USING A THINNER BLADE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8629507 ↗MalfunctionApr 30, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SAW BLADE AND ANGEL WING WOULD NOT FIT THROUGH THE 12 MM POSTERIOR AUGMENT CUTTING GUIDE. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8566496 ↗MalfunctionMar 25, 2019Material Twisted/Bent; Material Twisted/Bent
IT APPEARS THAT THE SLIT FOR THE POSTERIOR CHAMFER CUT IS DAMAGED SO A SAW BLADE WILL NOT PASS. NO SIGNIFICANT DELAY. THE DEVICE IS BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8450344 ↗MalfunctionJan 21, 2019Material Twisted/Bent; Material Twisted/Bent
SIZE 7 ATTUNE REVISION AP BLOCK WAS BENT, CLOSING DOWN THE POSTERIOR CAPTURE AND NOT ALLOWING SAW BLADE TO PASS THROUGH.
Patient problems: No Code Available
MAUDE report 8264644 ↗MalfunctionJan 18, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
A DECISION WAS MADE TO UTILISE THE ATTUNE REVISION SYSTEM. DURING THE COURSE OF THE PROCEDURE THE CONVENTIONAL FEMORAL CUTTING BLOCK WAS UTILISED. THIS WAS POSITIONED AND PINNED IN PLACE. WHEN ATTEMPTING TO MAKE THE POSTERIOR CHAMFER CUT THROUGH THE SAW SLOT, IT WAS FOUND THAT THE SAW BLADE COULD NOT FIT THROUGH THE SLOT. THE SLOT WAS THEN CHECKED WITH THE ANGLE WING AND IT WAS FOUND THAT THIS ALSO, DID NOT FIT THROUGH THE POSTERIOR CHAMFER SLOT. THIS HAD A SHORT DELAY IN THE SURGERY AND REQUIRED THE POSTERIOR CHAMFER BE RESPECTED FREEHAND. THIS IS A NEW ATTUNE REVISION KNEE SET, SO THIS WOULD BE THE FIRST TIME THIS INSTRUMENT HAS BEEN UTILISED.
Patient problems: Not Applicable
MAUDE report 8261872 ↗MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent
CUTTING BLOCK WAS FOUND TO BE DEFORMED. IT WAS BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8146569 ↗
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
- ATTUNE 2545-00-158Depuy (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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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