ATTUNE 2545-00-736Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 6 LEFT · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune femoral trial is a knee surgery trial instrument. Many of the 125 reports describe trial parts that broke, cracked, or were scratched, and most say no patient was affected. The reports include no deaths and 2 injuries. Reports fell to 2 in the last 12 months from 8 in the previous 12. 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
- 126
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10603295134084), received between Aug 24, 2017 and Sep 25, 2026 — classified as 2 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Break” (63 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
- Break63
- Scratched Material28
- Crack19
- Naturally Worn10
- Appropriate Device Problem Term/Code Not Available7
- Material Deformation5
- Material Twisted/Bent5
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- No Consequences Or Impact To Patient49
- Insufficient Information7
- No Information6
- Bone Fracture(s)1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898218 ↗MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT DURING OFFICE INSPECTION A FRACTURE WAS FOUND ON THE BACK PORTION OF FEMUR TRIALS. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222624 ↗MalfunctionFeb 5, 2026Break; Scratched Material
IT WAS REPORTED THE FEMORAL TRIAL WAS SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268176 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438870 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435714 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435711 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435684 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS REPORTED BROKEN. DATE OF DAMAGE WAS UNKNOWN AS THE DAMAGE WAS NOTED IN STERILE PROCESSING DEPARTMENT. THERE WAS NO NEGATIVE PATIENT OUTCOME REPORTED, AND NO EXTENSION OR DELAYS TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22674990 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: Insufficient Information
MAUDE report 22197407 ↗MalfunctionApr 29, 2025Break; Break
IT WAS REPORTED DURING LOAN KIT INSPECTION IT WAS NOTED THE FEMORAL TRIAL INSERT HAS DAMAGE TO THE OUTER FACE NEAR THE TOP. THERE IS NO PROCEDURE OR PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926097 ↗MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, AND THE FEMORAL TRIAL WAS BROKEN. THERE WAS NO DELAY AND STAFF WERE ABLE TO FINISH WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 20795348 ↗MalfunctionSep 27, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE ALLEGATION IS UNKNOWN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321627 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKE AND NEEDING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20247267 ↗MalfunctionSep 4, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137705 ↗MalfunctionAug 13, 2024Break; Break
BROKEN CONSIGNED INSTRUMENTS NEEDING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977454 ↗MalfunctionJul 23, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT ALL THE FEMORAL TRIALS ARE BECOMING CHIPPED AND WORN FROM TOO MUCH USE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19807150 ↗MalfunctionJul 23, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT ALL THE FEMORAL TRIALS ARE BECOMING CHIPPED AND WORN FROM TOO MUCH USE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19806925 ↗MalfunctionJul 23, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT ALL THE FEMORAL TRIALS ARE BECOMING CHIPPED AND WORN FROM TOO MUCH USE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19806871 ↗MalfunctionJun 28, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE FEMORAL TRIALS ARE CRACKED AND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19635336 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THAT WHILE IMPACTING THE FEMORAL TRIAL IT BROKE IN HALF. NO HARM TO PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19151625 ↗MalfunctionApr 9, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN AND WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19070014 ↗MalfunctionApr 5, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN/WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049952 ↗MalfunctionMar 21, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIALS HAD SIGNIFICANT SCRATCHES/GOUGES. MAINLY SIZE 6 AND 7 TRIALS. CAN THIS PLEASE BE LOOKED AT OR SWAPPED OUT. IT WAS FROM A LOAN TRAY (ZNAUK0817) WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY NO, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18951724 ↗MalfunctionMar 21, 2024Crack; Crack
IT WAS REPORTED THAT THERE WAS CRACK IN THE TRIAL CLOSE TO THE CATALOG NUMBER. ADDITIONALLY, SCRATCHES, FROM SAW BLADE EXCURSION, WERE FOUND ON EXTERNAL SURFACE; AND AN UNKNOWN SUBSTANCE ON INNER SURFACE OF DEVICE.
Patient problems: Insufficient Information
MAUDE report 18948733 ↗MalfunctionOct 2, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17851206 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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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