ATTUNE 2545-05-436Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM INSERT TRIAL HANDLE · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE knee system insert trial handle is a hand instrument surgeons use to fit trial inserts before implanting a knee replacement. The 35 reports mostly describe the handle breaking, bending, or warping so it no longer holds the trial insert, and sometimes not fitting other instruments. No deaths or injuries were reported, and in the cases described nothing was left behind in the patient. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295481652), received between May 30, 2019 and May 21, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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
- Device-Device Incompatibility17
- Material Deformation16
- Break14
- Contamination /Decontamination Problem2
- Crack1
- Naturally Worn1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information8
- No Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT THE HANDLE HAD A CUT IN THE RUBBER. THERE WERE NO DELAYS. NOTHING WAS LEFT IN THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243722 ↗MalfunctionMay 21, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TRIAL HANDLE PRONG BENT AND NO LONGER FIT THE TRIALS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243062 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT THE HANDLE WAS BROKEN WHILE INSERTING THE TRIAL INSERT. ALL PIECES WERE RETRIEVED AND NOTHING WAS LEFT BEHIND. THE INSTRUMENT NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176742 ↗MalfunctionApr 7, 2026Material Deformation
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS STRIPPED ON THE RUBBER. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24798933 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782779 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782765 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780691 ↗MalfunctionNov 10, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE INSERT TRIAL HANDLE PRONG IS BENT AND WILL NOT ACCEPT POLY TRIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513720 ↗MalfunctionNov 10, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE TRIAL HANDLE IS LOOSE AND WILL NOT HOLD TRIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513627 ↗MalfunctionOct 31, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE INSERT TRIAL HANDLE CONNECTOR TIP BENT WHILE THE INSERT TRIAL WAS BEING SEATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439242 ↗MalfunctionSep 5, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE GRAY HANDLE FOR THE SOLID POLY TRIALS HAS A BENT PRONG AND WON'T LOCK INTO THE TRIALS ANYMORE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977362 ↗MalfunctionJun 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT INSERT HANDLE BENT AND IT NO LONGER FITS IN THE TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328504 ↗MalfunctionApr 1, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE GREY TRIAL HANDLE PRONGS WERE BENT AND IT NO LONGER FITS THE TRIALS.
Patient problems: Insufficient Information
MAUDE report 21746037 ↗MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT THE GREY INSERT TRIAL HANDLE BROKE.
Patient problems: Insufficient Information
MAUDE report 21655643 ↗MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT THE GREY INSERT TRIAL HANDLE BROKE.
Patient problems: Insufficient Information
MAUDE report 21655635 ↗MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT THE GREY INSERT TRIAL HANDLE BROKE.
Patient problems: Insufficient Information
MAUDE report 21655628 ↗MalfunctionDec 10, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED THAT WHILE TRAILING POLY INSERT SIZES IT WAS DETERMINED THAT THE TRIAL HANDLE HAD A DEEP SLIT IN THE HANDLE. OUT OF CONCERN THAT THE INSTRUMENT MIGHT NOT BE STERILE IN THAT AREA, IT WAS REMOVED FROM THE FIELD. THE SYNTHETIC RUBBER HAS OTHER TEARS AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20888850 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED ON OCTOBER 30, 2024 THAT THE RED BUTTON ON THE HANDLE BROKE OFF. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20682952 ↗MalfunctionJun 24, 2024Break; Break
IT WAS REPORTED THAT THE SPRING ON INSERTED WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 19596542 ↗MalfunctionJun 17, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE TRIAL INSERT HANDLE HAS A BENT PRONG SO IT DOES NOT FIT PROPERLY IN THE TRIAL INSERTS. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19546538 ↗MalfunctionSep 26, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE INSTRUMENT DID NOT BREAK INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17816673 ↗MalfunctionAug 30, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS BROKEN AND CAN NO LONGER HOLD ONTO THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650151 ↗MalfunctionAug 30, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE IS BROKEN AND CAN NO LONGER HOLD ONTO THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650090 ↗MalfunctionJul 20, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17368401 ↗MalfunctionJul 20, 2023Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17368379 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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