ATTUNE 2545-00-734Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED 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 post, a size 4 left template used to try implant sizes during hip surgery, has 61 adverse event reports. The reports mostly describe the plastic trial component breaking, cracking, chipping or scratching, with one report of a bone fracture;60 malfunctions, 1 injury and no deaths. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295134060), received between Nov 6, 2017 and Jun 18, 2026 — classified as 1 injury, 60 malfunctions.
The most frequently reported specific device problem is “Break” (20 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
- Break20
- Scratched Material20
- Naturally Worn7
- Crack6
- Material Deformation5
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available2
- Corroded2
Patient problems
- No Consequences Or Impact To Patient30
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information5
- Bone Fracture(s)1
- No Information1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT THE OUTER SURFACE OF THE TRIAL SHELL WAS CHIPPED. THE DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25548279 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438916 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435693 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435690 ↗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 20645546 ↗MalfunctionSep 30, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334064 ↗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 20321620 ↗MalfunctionJul 25, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INSTRUMENT BROKE INTO TWO PIECES.
Patient problems: Insufficient Information
MAUDE report 19826525 ↗MalfunctionJul 25, 2024Break; Break
A BREAKAGE OCCURRED DURING THE IMPACTION OF FEMUR TESTS AND THE CLAMP USED TO PULL PINS NO LONGER GRASPED THE PINS. USE OF ANOTHER ORTHOKIT TO COMPLETE THE PROCEDURE. SURGICAL DELAY OF 20 MINUTES, PROLONGATION OF ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 19826504 ↗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 19810009 ↗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 19809912 ↗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 19809693 ↗MalfunctionJun 21, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION RECEIVED: A. IT WAS STATED THAT THE PLASTIC ORANGE CLAMPING RING IS DAMAGED. PLEASE CLARIFY WHAT DO YOU MEAN BY DAMAGE? WAS IT BROKE, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? IT HAS A CHIP IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580447 ↗MalfunctionJan 12, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT SAW CUT ON FEMORAL TRIAL 4 LEFT PS IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502656 ↗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 17408324 ↗MalfunctionFeb 20, 2023Break; Break
IT WAS REPORTED THAT FEMUR TRIAL BROKE IN TWO PIECES WHILE BEING IMPACTED. BOTH PIECES WERE BEING RETURNED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16403832 ↗MalfunctionApr 4, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT IS PEELING ON THE TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13994408 ↗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 12577614 ↗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 12577598 ↗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 12577512 ↗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 12577478 ↗MalfunctionSep 28, 2021Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE BROKE IN HALF WHILE SURGEON ATTEMPTED TO REMOVE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12540066 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICED CROUTINE INSPECTION. NO SURGICAL DELAYLS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12431970 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICING ROUTINE INSPECTION. NO SURGICAL DELAYS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12431967 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICED CROUTINE INSPECTION. NO SURGICAL DELAYLS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12431950 ↗
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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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