ATTUNE 2545-00-725Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 5 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 knee sizing template used during knee replacement surgery. Its 101 FDA reports include no deaths and no injuries, and mostly describe instruments breaking, cracking, or getting scratched, with some reports of a trial breaking during surgery. Reports fell to 2 in the last 12 months from 8 before. 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
- 102
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10603295133971), received between Nov 7, 2017 and Sep 25, 2026 — classified as 102 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 Material33
- Crack18
- Naturally Worn10
- Appropriate Device Problem Term/Code Not Available5
- Material Deformation4
- Contamination /Decontamination Problem3
- Device-Device Incompatibility3
Patient problems
- No Consequences Or Impact To Patient52
- No Clinical Signs, Symptoms or Conditions46
- Insufficient Information4
- No Code Available3
- No Information1
Recent adverse event reports
The 25 most recent of 102 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 50903853 ↗MalfunctionJun 16, 2026Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS WERE SCRATCHED FROM EVERYDAY WEAR AND TEAR AND WERE DEEMED UNABLE TO BE STERILIZED BY THE STERILE PROCESSING MANAGER. THIS DID NOT OCCUR DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25521674 ↗MalfunctionMar 30, 2026Break; Crack
IT WAS REPORTED THAT TRIALS WERE CRACKED OR BROKEN AND THE HOSPITAL WILL NOT ACCEPT THEM. THE ANGEL WING WAS BENT, AND THE TIBIA IMPACTOR HAS POPPED ITS SPRING. THE POLY LOST A SPRING ON ONE OF THE POSTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24730368 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438880 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435854 ↗MalfunctionJul 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ARTIFICIAL JOINT REPLACEMENT SURGERY USING ATTUNE FOR BILATERAL KNEE OSTEOARTHRITIS ON RIGHT KNEE PERFORMED WITH THE PRODUCT IN QUESTION. IN THE SURGERY WHEN INSERTING THE FEMORAL TRIAL, THE PRODUCT WAS GRASPED WITH THE ATTUNE FEMORAL TRIAL HOLDER AND DRIVEN, AND IT WAS BISECTED IN TWO. BECAUSE IT WAS NOT CRUSHED, THERE WERE NO FRAGMENTS GENERATED, AND AFTER THOROUGH CLEANING TO CONFIRM THAT THERE WERE NO FRAGMENTS, THE SURGERY CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589206 ↗MalfunctionMay 21, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT SURGEON DAMAGED TRIAL WITH SAW WHEN RESECTING PATELLA. TRIAL SCRATCHED AND MARRED FROM SAW. TRIAL WAS IN ONE PIECE.
Patient problems: Insufficient Information
MAUDE report 22062534 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE IN HALF ON IMPACTING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21997486 ↗MalfunctionJan 10, 2025Material Discolored; Illegible Information; Material Discolored; Illegible Information
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COLOUR HAD WORN OFF THE FEMORAL TRIALS. THE EVENT WAS MANAGED WITHOUT COLOURS. THERE WAS NO REPORTED PROCEDURE OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124683 ↗MalfunctionNov 25, 2024Break; Break
IT WAS REPORTED THAT DURING IMPACTION OF A FEMORAL TRIAL, THE SIZE 5 INSTRUMENT BROKE. THERE WAS NO DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772564 ↗MalfunctionNov 8, 2024Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THEY ARE NOT SURE IF THE DEVICE BROKE INTO TWO OR MORE PIECES. THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20645291 ↗MalfunctionSep 30, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20336216 ↗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 20321637 ↗MalfunctionAug 28, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
INSTRUMENTS HAVE GOUGE MARKS AND CHIPS FROM WEAR AND TEAR. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20089656 ↗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 19809919 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806283 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806209 ↗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 19049949 ↗MalfunctionMar 20, 2024Break; Break
BROKEN/ DAMAGED INSTRUMENTS AT HOSPITAL NEEDING REPLACEMENTS. NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18941773 ↗MalfunctionFeb 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THERE WAS WEAR AND TEAR DUE TO HIGH VOLUME USAGE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730896 ↗MalfunctionDec 27, 2023Break; Break
IT WAS REPORTED THAT THE ANTERIOR PORTION BROKE OFF TRIAL FEMUR. ALL PIECES RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18402800 ↗MalfunctionNov 30, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED: A. WERE THERE ANY ADVERSE CONSEQUENCES AFFECTING THE PATIENT DUE TO THE REPORTED EVENT? NO. B. WAS THERE A SURGICAL DELAY? IF SO, WHAT IS THE DURATION OF THE DELAY? THERE WAS NO DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18236114 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT THE PS FEMUR TRIAL BROKE DURING IMPACTION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17859778 ↗MalfunctionAug 2, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17443973 ↗MalfunctionJul 27, 2023Corroded; Material Discolored; Contamination /Decontamination Problem; Corroded; Material Discolored; Contamination /Decontamination Problem
DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: DURING A LOAN KIT INSPECTION, THE INSTRUMENTS WERE FOUND TO HAVE BLACK SPOTS ALL OVER THE THEM. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17407750 ↗
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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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