ATTUNE 2545-00-724Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 4 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 post is a sizing template used during hip replacement surgery to measure the femoral canal before implanting the real parts. The reports mostly describe the plastic template breaking, cracking or chipping during impaction, plus scratches, discoloration and worn surfaces; in most cases surgery continued with another tray and no lasting harm. There are 49 reports, 1 injury and no deaths, and 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
- 49
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295133964), received between Oct 10, 2017 and Jul 1, 2026 — classified as 1 injury, 48 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Scratched Material13
- Crack11
- Naturally Worn4
- Material Discolored3
- Appropriate Device Problem Term/Code Not Available2
- Device-Device Incompatibility2
- Illegible Information2
Patient problems
- No Consequences Or Impact To Patient25
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information3
- No Information2
- Bone Fracture(s)1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT DURING IMPACTION OF THE FEMORAL TRIAL, THE FEMORAL TRIAL BROKE. THIS DID NOT IMPACT THE LENGTH OF THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680550 ↗MalfunctionDec 21, 2025Break; Break
WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? ANOTHER TRAY NEEDED TO BE OPENED WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? BY 3 MINUTES HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. PLEASE GIVE A DETAILED EXPLANATION OF EVENT: THE POSTERIOR CONDYLE OF THE FEMUR TRIAL BROKE OF DURING IMPACTION ONTO THE FEMUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861277 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435850 ↗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 20321628 ↗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 19806954 ↗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 19806931 ↗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 19806819 ↗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 17409924 ↗MalfunctionJul 21, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE FEMORAL TRIAL HAS BROKEN IN HALF. THERE WAS A CRACK AND BROKEN THROUGH UPON IMPACTION. ALL PIECES WERE RECOVERED. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073099 ↗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 12578104 ↗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 12577763 ↗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 12577748 ↗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 12577489 ↗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 12431997 ↗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 12431988 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF N DURING ROUTINE INSPECTION. NO SURGICAL DELAYLS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12431987 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF N DUCED CROUTINE INSPECTION. NO SURGICAL DELAYLS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12431971 ↗MalfunctionJul 8, 2021Break; Break
IT WAS REPORTED THE INSTRUMENT WAS BROKEN WHILE IMPACTING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12135807 ↗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 11825995 ↗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 11629427 ↗MalfunctionJan 4, 2021Material Integrity Problem; Material Integrity Problem
IT WAS STATED THAT FEMORAL TRIALS ARE DAMAGED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11113630 ↗MalfunctionOct 8, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ORANGE RING WAS CHIPPED AND CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10650207 ↗MalfunctionSep 24, 2020Crack; Crack
IT WAS REPORTED THAT THERE WERE CRACKED ON FEMUR TRIALS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10583048 ↗MalfunctionAug 21, 2020Break; Break
IT WAS REPORTED THAT THE SIZE 4 RIGHT FEMORAL TRIAL IS BROKEN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10436594 ↗InjuryJul 22, 2020Break; Break
DURING IMPACTION THE LATERAL CONDYLE OF THE ATTUNE FEMORAL TRIAL BROKE OFF (254500724) . AS THE PIECES OF THE BROKEN TRIAL WERE REMOVED IT WAS FOUND THAT THE PATIENT HAD DEVELOPED A NON DISPLACED LATERAL FEMORAL CONDYLAR FRACTURE STARTING AT THE ANTERIOR PORTION OF THE BOX RESECTION AND EXTENDING TO THE POSTERIOR PORTION OF THE FEMUR. THIS WAS REPAIRED USING TWO 4.0MM CANNULATED SCREWS AND THE SURGERY WAS FINISHED WITH NO FURTHER INCIDENT.
Patient problems: Bone Fracture(s); Not Applicable
MAUDE report 10309167 ↗
Other TEMPLATE devices
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- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
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- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
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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