ATTUNE 2544-00-007Recalls & reported problems
Depuy (Ireland) · ATTUNE ADJUSTABLE TIBIAL STYLUS · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE adjustable tibial stylus is a surgical alignment tool used during knee replacement procedures. The 65 reports mostly describe parts breaking or cracking during surgery, stylus pieces not calibrating properly, missing handles, and measurement errors, with surgeons noting sticking balancers and incompatible parts. No deaths or injuries are reported. There are no recalls naming this device, and reports in the past 12 months (11) were somewhat higher than the 6 in the prior 12 months.
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
- 65
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295129790), received between Feb 5, 2018 and May 11, 2026 — classified as 65 malfunctions.
The most frequently reported specific device problem is “Break” (30 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
- Break30
- Crack12
- Incorrect Measurement8
- Material Twisted/Bent4
- Mechanical Jam4
- Device-Device Incompatibility3
- Material Deformation2
- Material Discolored2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- No Consequences Or Impact To Patient16
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Incorrect Measurement
IT WAS REPORTED THAT THE SURGEON STATES THAT THE STYLUS WAS NOT CALIBRATED AND BALANCER WAS STICKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135092 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED THAT THE RED TAB BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111511 ↗MalfunctionMay 7, 2026Incorrect Measurement
IT WAS REPORTED THAT THE SURGEON STATED THE STYLUS WAS NOT CALIBRATED AND THAT THE BALANCER WAS STICKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110594 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT THE ATTUNE DEVICE WAS BROKEN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926082 ↗MalfunctionApr 8, 2026Crack
IT WAS REPORTED THAT THE TIBIAL STYLIST WAS CRACKED. ALL PIECES RETRIEVED. THERE WAS NO DELAY AND NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820519 ↗MalfunctionApr 8, 2026Crack
IT WAS REPORTED THAT THE TIBIAL STYLIST WAS CRACKED. ALL PIECES RETRIEVED. THERE WAS NO DELAY AND NO COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820514 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT IT WAS NOTICED DURING THE PRE-SURGICAL SETUP THAT THE RED HANDLE ON THE STYLUS WAS MISSING. THEY HAD ANOTHER STYLUS AVAILABLE. THERE WAS NO DELAY IN THE CASE. IT WAS NOTICED DURING THE PRE-SURGICAL SETUP THAT THE FEMORAL IMPACTOR TIP WAS CRACKED. WE HAD ANOTHER IMPACTOR AVAILABLE. NO DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430197 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE STYLUS "FINGER" END BROKE. IT WAS REPORTED THAT THE BROKEN PIECE WAS RETRIEVED. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE AND NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193641 ↗MalfunctionJan 12, 2026Crack
IT WAS REPORTED THAT BOTH IMPACTOR TIPS HAD A CRACK ALONG THE FRONT. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032015 ↗MalfunctionDec 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ATTUNE TIBIAL STYLUS NO LONGER STAYS FIXED ON DIALED RESECTION VALUES. VERY DIFFICULT TO USE WHILE OPERATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794359 ↗MalfunctionDec 11, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT STERILE PROCESSING DEPART BROUGHT IT TO ATTENTION THAT THE TIBIAL STYLUS WAS BROKEN. UPON ASSESSMENT, THE INTERNALS OF THE STYLUS WAS NOT WORKING CORRECTLY AND ALLOWING THE STYLUS TO RAISE AND LOWER. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782353 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT THE TIBIAL STYLUS WAS BROKEN. IT DID NOT DELAY THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290516 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT A PIECE OF THE RED HANDLE ON THE TIBIAL SIZER BROKE OFF AND WILL NEED TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961990 ↗MalfunctionApr 22, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE TIBIA STYLUS ROTATES PAST 10MM NOT ACCURATE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21881663 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT WHILE REASSEMBLING INSTRUMENTS IN STERILE PROCESSING, IT WAS NOTED THAT THE RED PULL TAB HAD BROKEN OFF THE STYLUS. ALL PIECES WERE ACCOUNTED FOR.
Patient problems: Insufficient Information
MAUDE report 21111302 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT RED HANDLE ON STYLUS WAS BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21103763 ↗MalfunctionNov 13, 2024Crack; Crack
IT WAS REPORTED THAT THE STYLUS CRACKED DURING THE CASE. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678428 ↗MalfunctionAug 13, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE INSTRUMENT KNOB WILL NOT TURN TO CHANGE DEPTH.
Patient problems: Insufficient Information
MAUDE report 19972320 ↗MalfunctionAug 13, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED, THAT THE INSTRUMENT KNOB WILL NOT TURN TO CHANGE DEPTH.
Patient problems: Insufficient Information
MAUDE report 19972261 ↗MalfunctionAug 8, 2024Crack; Crack
IT WAS REPORTED THAT THE STYLUS HANDLE IS CRACKED. THIS WAS DISCOVERED DURING CASE SETUP. IT DID NOT HAPPEN IN SURGERY. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945765 ↗MalfunctionAug 8, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PRIMARY TOTAL KNEE ARTHROPLASTY, THE SURGEON NOTED THAT THE ATTUNE STYLUS WOULD NOT CHANGE RESECTION DEPTH MEASUREMENTS PROPERLY. THE SPRING WAS JAMMED. THERE WERE NO PIECES BROKEN OFF. THERE WAS NO DELAY OR COMPLICATION TO THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 19937531 ↗MalfunctionAug 6, 2024Crack; Illegible Information; Crack; Illegible Information
IT WAS REPORTED THAT THE RED HANDLE OF ATTUNE STYLUS IS CRACKED AND NEEDS TO BE REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19918992 ↗MalfunctionApr 25, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED BY SPD DUE TO BROKEN PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19179836 ↗MalfunctionFeb 15, 2024Break; Break
IT WAS REPORTED THAT THE RED HANDLE BROKE OFF STYLUS RED KNOBS BROKE OFF BOTH FEM INTRODUCERS. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18715058 ↗MalfunctionNov 17, 2023Structural Problem; Structural Problem
IT WAS REPORTED THAT THE STYLUS DOES NOT LOCK IN AND FREELY FLOATS BACK AND FORTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18158853 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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