ATTUNE 2545-00-707Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 7 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 surgery. Most of the 82 reports describe the trial snapping or cracking during insertion or movement, and some describe needing a replacement during surgery. 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 10603295133797), received between Oct 8, 2018 and Jun 5, 2026 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Break” (52 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
- Break52
- Scratched Material17
- Naturally Worn10
- Crack8
- Illegible Information4
- Material Discolored4
- Material Twisted/Bent4
- Peeled/Delaminated4
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Consequences Or Impact To Patient22
- Insufficient Information6
- No Code Available3
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT THE TRIAL FEMUR SNAPPED WHEN TRIALING IN CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25415311 ↗MalfunctionJun 3, 2026Break; Crack
IT WAS REPORTED THAT THE DR. SNAPPED TRIAL DEVICE ON HANDS AFTER IT CRACKED FROM IMPLANTATION. IT WAS REPORTED THAT ALL FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25376255 ↗MalfunctionMar 16, 2026Break
IT WAS REPORTED THAT FEMUR TRIAL BROKE WHEN TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604069 ↗MalfunctionDec 29, 2025Break; Break
IT WAS REPORTED THAT, DURING INSERTION WITH AN SRI INSERTER, THE TRIAL CRACKED. THE BROKEN FRAGMENTS WERE VISUALLY REMOVED, AND A STERILIZED REPLACEMENT WAS OBTAINED FROM AN ADJACENT FACILITY AND USED. THIS REPLACEMENT PROCESS INCREASED THE OPERATIVE TIME BY APPROXIMATELY TWENTY MINUTES; THE SURGERY WAS OTHERWISE COMPLETED SUCCESSFULLY WITHOUT FURTHER DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23912883 ↗MalfunctionDec 4, 2025Break; Break
IT WAS REPORTED THAT THE DOCTOR WAS TAKING THE LEG THROUGH A RANGE OF MOTION WITH THE TRIAL IN AND ONE OF THE CONDYLES ON THE FEMORAL TRIAL SNAPPED OFF. IT WAS BROKEN INTO TWO PIECES AND BOTH PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716249 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THAT POSTERIOR CHONDYLE ON TRIAL BROKE OFF WHILE TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064869 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT SIZE 7 RIGHT CR TRAIL BROKE WHEN TRAILING. A COUPLE PIECES BROKE OFF WHEN IMPACTING THE TRAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645224 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL SIZE 7 CR RIGHT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495086 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL BROKE WHILE TRAILING. NO DELAY IN SURGERY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331072 ↗MalfunctionJun 24, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRAIL BROKE WHILE FRIALING. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320322 ↗MalfunctionJun 23, 2025Break; Break
IT WAS REPORTED THAT RED KNOBS BROKE OFF BOTH INSERTERS. FEMUR TRIAL BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309313 ↗MalfunctionApr 17, 2025Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material
IT WAS REPORTED THAT THE TRIALS GOUGED/FLAKING.
Patient problems: Insufficient Information
MAUDE report 21857062 ↗MalfunctionMar 14, 2025Break; Break
IT WAS REPORTED THAT DURING REMOVAL OF THE TRIAL FEMUR AFTER TRAILING, THE TRIAL BROKE. THERE WAS NO DELAY IN CASE, THE PATIENT WAS NOT HARMED, AND ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21609910 ↗MalfunctionSep 25, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE. NO INFORMATION AS TO HOW THEY BROKE WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305753 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT FEMORAL TRIAL BROKE WHEN PUTTING LEG THROUGH RANGE OF MOTION.
Patient problems: Insufficient Information
MAUDE report 20206493 ↗MalfunctionAug 13, 2024Break; Break
BROKEN CONSIGNED INSTRUMENTS NEEDING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977565 ↗MalfunctionAug 13, 2024Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS REQUIRING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19974738 ↗MalfunctionJun 25, 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 19609443 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE BEING IMPACTED ON FEMUR.
Patient problems: Insufficient Information
MAUDE report 19490119 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE WHILE BEING IMPACTED ON FEMUR.
Patient problems: Insufficient Information
MAUDE report 19485030 ↗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 19458150 ↗MalfunctionMay 1, 2024Break; Break
IT WAS REPORTED THAT THE ATTUNE SZ 7 RIGHT CR FEMORAL TRIAL BROKE OFF THE POSTERIOR CONDYLE WHEN SURGEON WAS IMPACTING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19219933 ↗MalfunctionApr 24, 2024Break; Crack; Break; Crack
AT A GENERAL CHECK OF THE FEMORAL TRIAL CRACKS WERE DISCOVERED IN THE SULCUS PART OF THE CS FEMORAL TRIALS AND CRACKS ON THE ANTERIOR SIDE OF THE BOX IN HET PS FEMORAL TRIALS. THE CRACKS CAN BE SEEN BY PUTTING TENSION ON THE TRIALS. AFTER INSPECTION WITH STRESS TEST ONE FEMORAL TRIAL BROKE IN TWO. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171641 ↗MalfunctionApr 24, 2024Break; Crack; Break; Crack
ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO. WERE THE BROKEN FRAGMENTS RETAINED IN THE PATIENT? (YES OR NO): NO. PLEASE STATE WHICH DEVICE BROKE IN 2 TO ENSURE NOT ALL 15 ARE CODED FOR BROKEN IF REMAINING DEVICES ARE ONLY CRACKED. THIS WILL IMPACT REPORTABILITY TO THE HEALTH AUTHORITY AT DAY 15 SO IT IS URGENT. ONE HAS BEEN BROKEN BUT WE DO NOT KNOW WHICH ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171611 ↗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 19154802 ↗
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- 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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