ATTUNE 2545-00-714Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 4 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 plastic sizing template used during knee replacement surgery to fit the real implant before it goes in. The 33 reports mostly describe the trial breaking or snapping during surgery or cleaning, along with scratches, worn spots, discoloration and hard-to-read markings. No deaths and no injuries were reported; surgeries went on, sometimes with a short delay or a fresh trial from another set. There have been no recalls.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295133865), received between Oct 9, 2018 and Feb 26, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Scratched Material11
- Naturally Worn5
- Illegible Information4
- Material Discolored4
- Contamination /Decontamination Problem3
- Material Deformation3
- Peeled/Delaminated3
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient8
- No Code Available2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
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 24456922 ↗MalfunctionJul 18, 2025Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE LATERAL PART OF THE TRIAL'S CONDYLE FRACTURED OFF THE INSTRUMENT. NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22544249 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854182 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE TRIAL FEMUR BROKE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WENT ON USING A NEW TRIAL FROM ANOTHER SET. THERE WAS A DELAY IN SURGERY OF TWO MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103716 ↗MalfunctionDec 12, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2024. A FEMORAL TRIAL BROKE DURING THE PROCEDURE; THE COATING HAS CHIPPED. NOTHING WAS LEFT INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20915771 ↗MalfunctionJun 28, 2024Break; Break
IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIAL IS BROKEN, PART OF THE TRIAL HAS SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638951 ↗MalfunctionJun 27, 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 19629344 ↗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 19171634 ↗MalfunctionJan 16, 2024Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT INSTRUMENTS HAS FADED WRITING AND /OR SCRATCHED SURFACES, ARE NO LONGER FIT FOR PURPOSE NEED REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18518900 ↗MalfunctionJan 9, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS HAD SCRATCHES AND CUTS, UNABLE TO BE STERILIZED. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18479792 ↗MalfunctionJan 9, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS HAD SCRATCHES AND CUTS, UNABLE TO BE STERILIZED. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18479750 ↗MalfunctionNov 27, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT ON THE FEMUR TRIALS IS CHIPPING. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209758 ↗MalfunctionNov 22, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PAINT IS CHIPPING OFF THE FEMORAL TRIAL; UNABLE TO USE. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18194187 ↗MalfunctionNov 14, 2023Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED FOR SCRATCH/DENTS. THEY WERE CONSIDERED UNACCEPTABLE BY THE STERILE PROCESSING DEPARTMENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133853 ↗MalfunctionNov 14, 2023Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED FOR SCRATCH/DENTS. THEY WERE CONSIDERED UNACCEPTABLE BY THE STERILE PROCESSING DEPARTMENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133779 ↗MalfunctionNov 14, 2023Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED FOR SCRATCH/DENTS. THEY WERE CONSIDERED UNACCEPTABLE BY THE STERILE PROCESSING DEPARTMENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133744 ↗MalfunctionJul 24, 2023Break; Break
IT WAS REPORTED THAT FEMUR TRIAL BROKE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17381458 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE CRACKED AFTER CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17165127 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE IN TWO PIECES AS THE SURGEON WAS REDUCING THE KNEE. ALL PIECES WERE RETRIEVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17164379 ↗MalfunctionApr 27, 2023Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE SPD DEPARTMENT FEMUR TRIALS HAVE SCRATCHES AND INDENTIONS THAT MAKE THEM IMPOSSIBLE TO CLEAN. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824480 ↗MalfunctionAug 18, 2022Break; Crack; Naturally Worn; Break; Crack; Naturally Worn
IT WAS REPORTED THAT TRIAL BROKE DUE TO WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15254538 ↗MalfunctionJun 22, 2022Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE PAINT ON THE ATTUNE TRIAL PROSTHESES IS COMING OFF. THERE HAVE BEEN SEVERAL INSTANCES OF LOOSE PAINT PARTICLES, HOPEFULLY THEY HAVE NOT BEEN LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14777202 ↗MalfunctionMar 16, 2022Break; Break
BROKEN SIZE 4 LEFT FEMORAL TRIAL, WHEN IMPACTED WITH MALLET IT CRACKED AND BROKE IN TWO. PHOTO ATTACHED. IF OTHER, DESCRIBE: REPLACEMENT, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? NO, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: HOSPITAL 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 13777917 ↗MalfunctionOct 8, 2021Naturally Worn; Naturally Worn
SEE WORD DOC FOR PRODUCT NUMBERS. IT WAS REPORTED THAT ALL OF THESE INSTRUMENTS ARE WORN OUT BEYOND SURGICAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12599224 ↗MalfunctionMar 29, 2021Material Discolored; Scratched Material; Material Discolored; Scratched Material
NOOSA CSSD INFORMED THERE IS DAMAGE TO SOME OF THE ATTUNE CR TRIAL INSTRUMENTS THAT ARE ON CONSIGNMENT. THEY HAVE ALSO NOTICED SOME OF THE COLOURED MARKINGS ARE COMING OFF DURING THE STERILISATION PROCESS - THE MARKINGS WERE FOUND IN THE BOTTOM OF THE TRAY. THEY HAVE ASKED FOR A COMPLETE REPLACEMENT OF ONE OF THESE TRAYS ON CONSIGNMENT. NO PATIENT CONSEQUENCE. FURTHER INFORMATION PROVIDED THAT TRIALS ARE SCRATCHED AND GAUGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11585582 ↗
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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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