ATTUNE 2504-40-608Recalls & reported problems

Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CONVENTIONAL CUT GUIDE SIZE 8 · Class 1

All models of ATTUNE (1475)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295438472), received between Mar 5, 2019 and Dec 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Device-Device Incompatibility1
Failure to Disconnect1
Material Deformation1
Material Twisted/Bent1
No Apparent Adverse Event1

Patient problems

No Clinical Signs, Symptoms or Conditions4
No Consequences Or Impact To Patient2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 9, 2025Break; Break
IT WAS REPORTED THAT THE SIZE 8 CONV CUT GUIDE INSTRUMENT BROKE IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758466 ↗
MalfunctionMay 12, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED AS "NEED NEW SIZE 8 REVISION CUTTING BLOCK".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16921384 ↗
MalfunctionNov 16, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HOLE WHERE THE BOX SECTION GUIDE FITS IN ON THE TOP IS NOT DRILLED WIDE ENOUGH SO IT DOES NOT SEAT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15805708 ↗
MalfunctionAug 2, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CUTTING BLOCK IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15148300 ↗
MalfunctionNov 12, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE CUTTING BLOCK WAS BENT WHILE PUTTING THE KNEE INTO FLECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9311176 ↗
MalfunctionMar 5, 2019Failure to Disconnect; Failure to Disconnect
DURING AN ATTUNE REVISION, DR. (B)(6) WAS HAVING A RESIDENT PIN THE CONVENTIONAL SIZE 8 CUTTING BLOCK WITH A THREADED HEADED PIN. WHILE DOING SO (CONVERGENT PIN HOLE) HE COULD WELD THE THREADED HEADED PIN TO THE CUTTING BLOCK WE THEN REMOVED THE CUTTING BLOCK WITH PIN STILL STUCK IN THE BLOCK. THE SURGICAL TECH TRIED PULLING THE PIN OUT WITH VICE GRIPS WHICH IS WHY BOTH ENDS ARE BROKEN. THE SURGERY WAS DELAYED MAYBE 3-5 MINUTES?? WE HAD A BACK UP TRAY THERE WHERE WE WERE ABLE TO USE ANOTHER SIZE 8 CUTTING GUIDE..
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8390760 ↗

Device details

UDI-DI	`10603295438472`
Brand	ATTUNE
Model	2504-40-608
Catalog no.	250440608
Company	Depuy (Ireland)
Product code	HTZ · INSTRUMENT, CUTTING, ORTHOPEDIC
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Other INSTRUMENT, CUTTING, ORTHOPEDIC devices

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ATTUNE 2544-00-522
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58 reports
SIGMA LCS 9505-01-229
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56 reports
SIGMA 2024-40-100
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43 reports
ATTUNE 2545-00-158
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41 reports
ATTUNE 2545-00-156
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
41 reports
SIGMA 2024-40-200
Depuy (Ireland) · INSTRUMENT, CUTTING, ORTHOPEDIC
40 reports
ATTUNE 2545-00-155
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39 reports

All INSTRUMENT, CUTTING, ORTHOPEDIC devices →

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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