ATTUNE 2545-00-723Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 3 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 trial piece used to check fit. The 24 reports that name its identifier describe the trials breaking, chipping, scratching or wearing out with repeated use, often noticed during kit inspection rather than surgery, 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295133957), received between May 16, 2018 and Nov 3, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Scratched Material8
- Naturally Worn4
- Illegible Information3
- Device-Device Incompatibility2
- Contamination /Decontamination Problem1
- Corroded1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient8
- Insufficient Information3
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452923 ↗MalfunctionSep 3, 2025Illegible Information; Illegible Information
IT WAS REPORTED THAT THE TRIALS THAT DO NOT HAVE COLOR MARKINGS ON THE NEED TO BE REPLACED. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22953217 ↗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 20321626 ↗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 19810331 ↗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 19810301 ↗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 19809702 ↗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 17409954 ↗MalfunctionOct 5, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 4 OF EACH SIDE, 24 TOTAL REPLACEMENT TRIAL FEMURS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577714 ↗MalfunctionOct 5, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 4 OF EACH SIDE, 24 TOTAL REPLACEMENT TRIAL FEMURS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577688 ↗MalfunctionOct 5, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 4 OF EACH SIDE, 24 TOTAL REPLACEMENT TRIAL FEMURS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577687 ↗MalfunctionOct 5, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 4 OF EACH SIDE, 24 TOTAL REPLACEMENT TRIAL FEMURS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577563 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICED ROUTINE INSPECTION. NO SURGICAL DELAYS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12432015 ↗MalfunctionMay 14, 2021Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE NOTCH GUIDES HAVE ALL LOST THE WHITE ON THE NUMBERS AND ALSO HAVE WEAR/GROOVES ON THE METAL SURFACES. THE FEMORAL TRIALS ARE DISCOLORED AND HAVE GOUGES ON THE SURFACE. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826092 ↗MalfunctionMay 14, 2021Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE NOTCH GUIDES HAVE ALL LOST THE WHITE ON THE NUMBERS AND ALSO HAVE WEAR/GROOVES ON THE METAL SURFACES. THE FEMORAL TRIALS ARE DISCOLORED AND HAVE GOUGES ON THE SURFACE. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826081 ↗MalfunctionApr 7, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE FOLLOWING ATTUNE FEMORAL TRIALS WERE REQUESTED TO BE REPLACED BY SPD AS THEY WERE BEAT UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11629403 ↗MalfunctionDec 18, 2020Scratched Material; Scratched Material
IT WAS REPORTED THAT WHILE PUTTING INSTRUMENTS TOGETHER THEY NOTICED THE ATTUNE SZ 3 FEMUR TRIALS WERE DAMAGED (GASHED). THEY LOOK LIKE THEY WERE HIT WITH AN OSTEOTOME OR SAW BLADE. THEY NEED REPLACEMENT AS STERILE PROCESSING WILL NO LONGER ACCEPT THEM. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11041260 ↗MalfunctionDec 6, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THESE TRIALS WERE SOME OF THE FIRST USED WHEN ATTUNE CAME OUT. THEY DO NOT FIT WELL. OFFICE AND NEWER SETS FIT BETTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9430818 ↗MalfunctionDec 6, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THESE TRIALS WERE SOME OF THE FIRST USED WHEN ATTUNE CAME OUT. THEY DO NOT FIT WELL. OFFICE AND NEWER SETS FIT BETTER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9430639 ↗MalfunctionOct 28, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS SCRATCHED AND GOUGES ON THEM. THESE ARE OUT OF OFFICE SET. NO SURGERY WAS EFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9246330 ↗MalfunctionOct 28, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS SCRATCHED AND GOUGES ON THEM. THESE ARE OUT OF OFFICE SET. NO SURGERY WAS EFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9246325 ↗MalfunctionOct 28, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS SCRATCHED AND GOUGES ON THEM. THESE ARE OUT OF OFFICE SET. NO SURGERY WAS EFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9246314 ↗MalfunctionFeb 13, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIALS HAD NICKS AND CUTS ON THEM. THEY ARE NOT SMOOTH ANYMORE. THESE ARE ALL OUT OF OFFICE SETS. NO SURGERY AND PATIENT WAS AFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8336527 ↗MalfunctionFeb 11, 2019Material Deformation; Material Deformation
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. OFFICE SETTING, DID NOT AFFECT ANY SURGERY NOR PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8325008 ↗MalfunctionMay 16, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIALS ARE WORN AND DAMAGED WITH PIECES OF PLASTIC MISSING. THE SURGEON HAVE COMPLAINED AND REQUESTED THAT THE TRIALS BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7518086 ↗
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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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