ATTUNE 2545-00-706Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 6 RIGHT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune femoral trial is a surgical sizing instrument used during knee replacement. Many of the 82 reports describe the trial breaking, cracking, or breaking off during use, and some describe damage found during cleaning and sterilization. The reports include no injuries and no deaths. 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
- 82
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295133780), received between Sep 14, 2017 and Jun 12, 2026 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Break” (46 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
- Break46
- Scratched Material19
- Naturally Worn12
- Crack11
- Material Deformation6
- Material Twisted/Bent5
- Peeled/Delaminated5
- Illegible Information4
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Consequences Or Impact To Patient28
- No Code Available4
- Insufficient Information3
- Bone Fracture(s)1
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT IT DID NOT OCCUR IN SURGERY. THE FEMUR TRIAL BROKE. THE STERILE PROCESSING DEPARTMENT WAS ALERTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25486966 ↗MalfunctionMay 5, 2026Break
IT WAS REPORTED THAT THE TRIAL PASS PROSTHESIS WAS BROKEN DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080924 ↗MalfunctionMay 4, 2026Break
IT WAS REPORTED THAT TRIAL PROSTHESIS OF THE ATTUNE IS COMPLETELY BROKE OFF. THIS HAPPENED WHILE HITTING THE BONE, INSTRUMENT BROKE COMPLETELY. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073726 ↗MalfunctionMay 1, 2026Break
THIS COMPLAINT REPORTS THE FEMOR TRIAL HAS BROKEN OFF DURING IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055519 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED THAT FEMORAL TRIAL CONDYLE BROKE UPON IMPACTION. THE FEMORAL IMPACTOR ALSO CRACKED UPON IMPACTION OF IMPLANTS. ALL PIECES WERE RETRIEVED AND SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861322 ↗MalfunctionMar 10, 2026Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT CEMENT HAS GOTTEN STUCK TO CUTS IN THE FEMORAL TRIAL AND SPD WILL NOT STERILIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557879 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION PROCESSES IT WAS OBSERVED THAT DEVICES EXHIBIT DAMAGE AND WEAR IN THE CONDYLE AREA. IN ADDITION CHIPS AND SCRATCHES ARE ALSO VISIBLE IN THE DEVICE PHOTOS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456905 ↗MalfunctionDec 16, 2025Break; Break
IT WAS REPORTED THAT POSTERIOR LATERAL CONDYLE OF THE FEMORAL TRIAL BROKE OFF WHILE TRIALING ROM. ALL PIECES WERE RECOVERED AND A NEW PAN WAS OPENED TO TRIAL THE FEMUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818786 ↗MalfunctionAug 18, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED THAT IT WAS BROUGHT TO USER'S ATTENTION THAT THE 6 RIGHT CR FEMUR TRIAL WAS DAMAGED FROM A SAW BLADE AND HOLDING BIO BURDEN. USER DID NOT KNOW WHEN IT HAPPENED. THERE WERE NO LOOSE PIECES. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22829377 ↗MalfunctionJul 11, 2025Break; Break
IT WAS REPORTED THAT THE 6 RIGHT FEMORAL TRIAL BROKE IN 2 PIECES WHILE IMPACTING TO TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22481441 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT FEMUR TRAIL BROKE UPON REMOVAL AFTER TRAILING. BOTH SECTIONS WERE REMOVED FROM THE FIELD. THERE WAS NO DELAY IN THE CASE. THERE WAS NO HARM DONE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337578 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE WHEN IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22330474 ↗MalfunctionApr 17, 2025Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material
IT WAS REPORTED THAT THE TRIALS GOUGED/FLAKING.
Patient problems: Insufficient Information
MAUDE report 21858333 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE DURING ROM TRIALING. OPENED ANOTHER PAN AND REPLACED THE THE TRIAL IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 21710827 ↗MalfunctionNov 25, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A DIATHERMY MARK/BURN FOUND ON CR TRIAL 6R SIZE FOLLOWING CASE BY CSSD. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770785 ↗MalfunctionNov 15, 2024Break; Break
IT WAS REPORTED ON OCTOBER 5, 2024 THE FEMUR TRIAL BROKE BY STERILE PROCESSING DEPARTMENT DURING CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20698297 ↗MalfunctionSep 26, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: 1. WHAT WAS THE EXACT ALLEGATION AGAINST THE TRIAL? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS-THREADED, OR ANY DEVICE INTERACTION? FEMUR TRIAL: THE EDGE AROUND THE LUG HOLE GUIDE WAS WEARING AWAY DUE TO OVERUSE. T-HANDLE: THE MIDDLE OF THE HANDLE WAS CRACKING. 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THESE ISSUES DID NOT CAUSE DELAYS OR COMPLICATIONS DURING SURGERY. 3. WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. 4. DID THE HANDLE BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS-THREADED, ETC.? YES, THE HANDLE WAS COMPLETELY CRACKED THROUGH THE MIDDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20317025 ↗MalfunctionAug 13, 2024Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS REQUIRING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19974768 ↗MalfunctionAug 12, 2024Crack; Crack
THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: THE IMPLANT TRIAL WAS CRACKING RIGHT ABOUT THE INTERCONDYLAR ARCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19965680 ↗MalfunctionJul 26, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT CHIPPED AFTER IMPACTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19837118 ↗MalfunctionJun 28, 2024Break; Break
FEMORAL CONDYLE SNAPPED WHILE IMPACTING ONTO FEMUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639076 ↗MalfunctionJun 28, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIALS ALL HAVE SCRATCHES AND KNICKS OUT THE PLASTIC. HOSPITAL WILL NOT ALLOW THEM TO BE USED IN CASES. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632360 ↗MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED THAT THE KNEE TRIALS WERE DAMAGED. IT WAS UNABLE TO USE. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458139 ↗MalfunctionMay 9, 2024Break; Crack; Break; Crack
FEMUR TRIAL IS CRACKED AND NEEDS REPLACING. IT BROKE INTO 2 PIECES, OUTSIDE PATIENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282071 ↗MalfunctionApr 22, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE FEMORAL TRIALS WERE WORN AND FLAKING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154804 ↗
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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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