ATTUNE 2545-00-716Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 6 LEFT · 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 knee replacement sizing trial. Reports mostly describe the plastic trial breaking or cracking, sometimes during surgery, with scratched or worn surfaces; they mention no patient harm. There are 81 adverse event reports naming this device; all are malfunctions, with no deaths and no injuries. 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
- 81
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10603295133889), received between Sep 27, 2017 and Jun 5, 2026 — classified as 81 malfunctions.
The most frequently reported specific device problem is “Break” (49 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
- Break49
- Scratched Material16
- Naturally Worn11
- Crack7
- Material Twisted/Bent5
- Contamination /Decontamination Problem4
- Illegible Information4
- Material Deformation4
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Consequences Or Impact To Patient21
- Insufficient Information5
- No Code Available4
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409824 ↗MalfunctionFeb 26, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. DID THE DEVICE BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN, OR CROSS THREADED? PLEASE EXPLAIN. - NO BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456925 ↗MalfunctionFeb 19, 2026Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem
POST TKR CSSD STAFF FOUND THE ATTUNE CR SIZE 6L FEMORAL TRIAL HAD A BURN MARK ON IT. IT IS UNABLE TO BE CLEANED/REMOVED AND THEY WANT A REPLACEMENT; ITEM IS FROM ATTUNE CR TRIALS SIZE 3-8 CONSIGNED TRAY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24393729 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CR TRIAL DEVICE WAS BROKEN DURING TRIAL. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208247 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN IN HALF DURING SURGERY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698165 ↗MalfunctionSep 15, 2025Break; Break
IT WAS REPORTED THAT FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050434 ↗MalfunctionMay 22, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE 6 LEFT PLASTIC FEMORAL TRIAL CRACKED WHILE STRIKING WITH BLACK UNIVERSAL IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22071329 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT THE 6L FEMUR TRIAL WAS SNAPPED IN HALF. THERE WAS NO PATIENT HARMED OR AFFECTED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761853 ↗MalfunctionApr 1, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE CRACKED DURING A PROCEDURE. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. PROCEDURE WAS ABLE TO BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21738288 ↗MalfunctionMar 20, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS DISCOLORATION/(METAL) ABRASION OF THE TRIALS. THE ISSUE WAS SEEN IN CSSD. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21654794 ↗MalfunctionJan 22, 2025Break; Break
IT WAS REPORTED THAT WHILE IMPACTING THE SIZE 6 LEFT FEMORAL TRIAL, THE TRIAL BROKE INTO TWO PIECES. THE CR FEMORAL TRIAL BROKE ON THE MEDIAL SIDE JUST ABOVE THE LUG DRILL HOLE. SURGERY WAS NOT DELAYED AND THERE WAS NO ADVERSE EFFECTS TO THE PATIENT. BOTH PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208479 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED THAT THE FEM TRIAL BROKE INTO TWO PIECES. NO HARM WAS DONE TO PATIENT AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20765475 ↗MalfunctionOct 16, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PLASTIC FEMORAL TRIALS FOR SIZE 6 CRUCIATE RETAINING LEFT AND RIGHT ARE OVER USED AND NEED TO BE REPLACED. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20464069 ↗MalfunctionOct 16, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PLASTIC FEMORAL TRIALS FOR SIZE 6 CRUCIATE RETAINING LEFT AND RIGHT ARE OVERUSED AND NEED TO BE REPLACED. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20463908 ↗MalfunctionOct 2, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE LUG DRILL WAS DULL. ALSO CEMENT IS STUCK ON THE FEMUR TRIAL AND CANNOT BE REMOVED. THIS DID NOT DELAY SURGERY.
Patient problems: Insufficient Information
MAUDE report 20350722 ↗MalfunctionSep 4, 2024Break; Break
IT WAS REPORTED THAT SIZE 6 L FEMUR TRIAL BROKE WHILE IMPACTING THE TRIAL. NO ISSUES RESULTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20133870 ↗MalfunctionAug 21, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20015254 ↗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 19609207 ↗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 19458147 ↗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 19458120 ↗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 19171620 ↗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 19171614 ↗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 19154806 ↗MalfunctionFeb 16, 2024Break; Break
IT WAS REPORTED THAT THE RED KNOB BROKE OFF FEMORAL INTRODUCER AND FEMORAL TRIAL BROKE INTO TO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18719648 ↗MalfunctionFeb 7, 2024Break; Break
IT WAS REPORTED THAT WHILE IMPACTING A FEM TRIAL ONTO THE PATIENT, THE FEM TRIAL BROKE INTO 2 PIECES. BOTH PIECES WERE RECOVERED, DECONTAMINATED, AND SAVED FOR RETURN. SINCE THIS HAPPENED THE SURGICAL TECH SCRUBBED IN THE CASE, CHECKED THE TRAYS FOR ANY OTHER BAD INSTRUMENTS. ALSO, FOUND A INSERT TOP WITH A DAMAGED SPRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18658940 ↗
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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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