ATTUNE 2545-00-733Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 3 LEFT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295134053), received between May 16, 2018 and Nov 8, 2024 — classified as 1 injury, 21 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 Material6
- Naturally Worn4
- Device Damaged by Another Device2
- Device-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Contamination /Decontamination Problem1
- Corroded1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient9
- Limb Fracture1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
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 20646225 ↗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 20321851 ↗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 19806297 ↗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 19806203 ↗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 19806155 ↗InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS DEVICE, WHEN HAMMERED, RESULTED IN A FRACTURE OF THE FEMUR. THE FRACTURE WAS FIXED WITH TWO COMPETITOR SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY.
Patient problems: Limb Fracture
MAUDE report 17781148 ↗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 17408479 ↗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 12577451 ↗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 12577432 ↗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 12577419 ↗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 12577399 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICED CRACKSNE INSPECTION. NO SURGICAL DELAYLS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12432004 ↗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 11041253 ↗MalfunctionMar 10, 2020Material Integrity Problem; Scratched Material; Material Integrity Problem; Scratched Material
IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIALS WERE DAMAGED WITH SAW BLADE. IT CANNOT BE RESTERILIZED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9810996 ↗MalfunctionJan 10, 2020Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
ATTUNE INSTRUMENT APPEARED TO BE SCUFFED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9575221 ↗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 9430655 ↗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 9430481 ↗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 9246266 ↗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 9246265 ↗MalfunctionMar 20, 2019Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIALS WERE CUT WITH SAW BLADE. TRIALS ARE STILL IN ONE PIECE AND CAN'T BE RE-STERILIZED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8437264 ↗MalfunctionFeb 14, 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 8339323 ↗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 7517906 ↗
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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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