ATTUNE 2545-00-718Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 8 LEFT · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE femoral trial is a knee implant template used to size parts during surgery. The 46 reports mostly describe the trial breaking or cracking, sometimes right on impact, along with scratched surfaces, discoloration and worn markings that made the numbers hard to read. No deaths and no injuries were reported; problems were generally limited to brief delays in surgery or none at all. There are no recalls for 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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295133902), received between Aug 15, 2018 and Sep 22, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Break” (31 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break31
- Scratched Material5
- Crack4
- Illegible Information4
- Material Discolored4
- Naturally Worn4
- Peeled/Delaminated3
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient10
- No Code Available2
- Bone Fracture(s)1
- Insufficient Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
It was reported that femoral trial broke while trialing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849595 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146996 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THE FEMORAL TRIAL FRACTURED. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199957 ↗MalfunctionApr 22, 2026Scratched Material; Illegible Information
IT WAS REPORTED THAT POST OPERATION, THE CR TRIAL DEVICES WERE OBSERVED TO BE DAMAGED. ACCORDING TO THE REPORT, THE DEVICES HAVE LARGE SCRATCH AND DIVOTS FROM THE SAW, AND ALL OF THE MARKINGS HAVE BEEN REMOVED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958443 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT WHEN IMPACTING THE 8 LEFT FEMORAL TRIAL, THE POSTERIOR-LATERAL CONDYLE OF THE TRIAL SNAPPED OFF. BACK UP SET WAS OPENED SO TRIALING AND LUG HOLE DRILLING COULD BE PERFORMED. CAUSE MINOR DELAY IN CASE BUT NO HARM TO THE PATIENT. THE BROKEN CONDYLE PIECE WAS RETRIEVED IN WHOLE BUT THROWN IN THE TRASH BEFORE CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094610 ↗MalfunctionNov 25, 2025Break; Break
IT WAS REPORTED THAT SZ 8 CR FEMUR TRIAL POSTERIOR CONDYLE SNAPPED OFF AFTER IMPACTION AND BEFORE USING THE LUG DRILL. NO HARM TO PATIENT. SMALL DELAY WHILE OPENING NEW CR TRAIL. ALL PIECES RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646735 ↗MalfunctionNov 21, 2025Break; Break
IT WAS REPORTED THAT SIZE 8 LEFT FEMORAL TRIAL BROKE UPON IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617517 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR HAD BROKEN INTO TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475428 ↗MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN WHILE TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406978 ↗MalfunctionJun 13, 2025Break; Break
IT WAS REPORTED THAT 2 X CR TRIAL FEMURS HAVE BROKEN INTO 2 PIECES. BOTH WERE DISPOSED OF AND ARE NOT AVAILABLE FOR RETURN. THERE WAS NO IMPACT TO THE PATIENT AND A 5 MIN DELAY TO SURGERY WHILE AN ADDITIONAL CR TRIALS TRAY WAS OPENED. THE STERILE SERVICES TEAM WERE UNABLE TO TELL ME WHEN THE INCIDENTS OCCURRED BUT CONTACTED ME YESTERDAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201915 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT RED KNOBS BROKE OFF BOTH INTRODUCERS AND FEM TRIAL BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21995089 ↗MalfunctionApr 23, 2025Crack; Crack
IT WAS REPORTED THAT FEMORAL TRIAL CRACKED WHEN IMPACTED.
Patient problems: Insufficient Information
MAUDE report 21894397 ↗MalfunctionMar 20, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THERE WAS DISCOLORATION/(METAL) ABRASION OF THE TRIALS. THE ISSUE WAS SEEN IN CSSD. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21654841 ↗MalfunctionApr 23, 2024Break; Break
- PROCEDURE: TOTAL KNEE REPLACEMENT IT WAS REPORTED THAT THE TRIAL FEMUR BROKE DURING TRIALING - WHEN DID THE EVEN OCCUR (PRE-OP/INTRA-OP/POST-OP)? INTRA OP - WAS THERE ANY PATIENT CONSEQUENCE? NO - WHAT ACTION WAS TAKEN TO RESOLVE THE ISSUE? REPLACE THE TRIAL FEMUR - HOW LONG WAS THE PROCEDURE PROLONGED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE (MINUTES)? 10 MINUTES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163866 ↗MalfunctionMar 12, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891627 ↗MalfunctionFeb 12, 2024Break; Break
IT WAS REPORTED THAT DURING TRIALING 8L CR FEMORAL TRIAL BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18691632 ↗MalfunctionDec 27, 2023Break; Break
IT WAS REPORTED THAT THE RED TIGHTENING KNOB BROKE OFF THE DEVICE AND THE POST CONDYLE BROKE OFF THE TRIAL FEMUR. ALL PIECES WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18406897 ↗MalfunctionDec 8, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18291797 ↗MalfunctionNov 29, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PAINT IS CHIPPING OFF THE FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226662 ↗MalfunctionNov 28, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRIALS HAVE CHIPPING PAINT AND CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18221945 ↗MalfunctionSep 12, 2023Break; Break
SURGEON BROKE CR TRIAL ON TRIALING DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE AND SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17733684 ↗MalfunctionMay 4, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE TRIAL IS CRACKED/CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16867974 ↗MalfunctionApr 28, 2023Break; Break
IT WAS REPORTED THAT UPON TRIAL REDUCTION UNDER STRESS THE FEMORAL TRIAL FRACTURED INTO 2 PIECES. BOTH PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16834403 ↗MalfunctionApr 20, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777651 ↗MalfunctionSep 13, 2022Break; Break
IT WAS REPORTED THAT CR FEMORAL COMPONENT BROKE INTO TWO PIECES DURING EXTRACTION OF FEMUR .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15410600 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page