ATTUNE 2545-00-735Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 5 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 surgical sizing template used in knee replacement. Reports describe trial parts cracking or breaking during impaction, bent pins and scratched surfaces. There are 111 reports, including 1 injury and no deaths, and reports in the last 12 months fell to 5 from 12. 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
- 111
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 10603295134077), received between Jan 4, 2018 and Mar 30, 2026 — classified as 1 injury, 110 malfunctions.
The most frequently reported specific device problem is “Break” (57 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
- Break57
- Scratched Material29
- Crack16
- Naturally Worn10
- Contamination /Decontamination Problem6
- Appropriate Device Problem Term/Code Not Available4
- Device-Device Incompatibility3
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Consequences Or Impact To Patient47
- Insufficient Information9
- No Code Available3
- Limb Fracture1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Break; Crack
IT WAS REPORTED THAT TRIALS WERE CRACKED OR BROKEN AND THE HOSPITAL WILL NOT ACCEPT THEM. THE ANGEL WING WAS BENT, AND THE TIBIA IMPACTOR HAS POPPED ITS SPRING. THE POLY LOST A SPRING ON ONE OF THE POSTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729999 ↗MalfunctionNov 21, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE DURING IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23618858 ↗MalfunctionNov 7, 2025Break; Break
IT WAS REPORTED THAT TRIAL FEMUR BROKE DURING IMPACTION, ALL PIECES RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23501338 ↗MalfunctionNov 7, 2025Break; Break
THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT, UPON OPENING THE PFC 3INHDLES STEINMN PIN PKG10, THE LEFT FIFTH FEMORAL PIN WAS FOUND TO BE BROKEN. DURING THE SURGERY, THE PINS WERE OBSERVED TO BE SEVERELY BENT, MAKING INSERTION INTO THE CUTTING GUIDES DIFFICULT. THERE WERE NO DELAYS OR COMPLICATIONS DURING THE PROCEDURE. THE TEAM ATTEMPTED TO SEPARATE THE MOST BENT PINS AND PROCEEDED WITH THOSE IN THE BEST CONDITION. THE TEST WAS NOT PERFORMED BECAUSE THE PATIENT WAS RIGHT-HANDED. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498893 ↗MalfunctionNov 4, 2025Break; Break
IT WAS REPORTED THAT THE PIECE WAS BROKEN UPON IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23472385 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438867 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435703 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435700 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435698 ↗MalfunctionJul 29, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22649420 ↗MalfunctionMar 6, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL BROKE DURING IMPACTION.
Patient problems: Insufficient Information
MAUDE report 21540056 ↗InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A LEFT LATERAL FEMORAL CONDYLE FRACTURE WHILE TRAILING FOR TOTAL KNEE. NEEDED TO USE 2 CANNULATED SCREWS TO FIX FRACTURE. APPROXIMATELY 15 MINUTES OF EXTENDED SURGICAL TIME.
Patient problems: Limb Fracture
MAUDE report 21457389 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL COMPLETELY SHATTERED DURING IMPACTING.
Patient problems: Insufficient Information
MAUDE report 21104860 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED THAT THE HOSPITAL HAD TWO 5L PLASTIC TRIALS BREAK DURING IMPACTING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20762981 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED THAT THE HOSPITAL HAD TWO 5L PLASTIC TRIALS BREAK DURING IMPACTING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20762835 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT THE SZ 5 PS FEMORAL TRIAL WAS BROKEN INTO 2 PIECES WHILE IMPACTING ONTO THE FEMUR. BOTH PIECES WERE RETRIEVED AND THERE WAS NO HARM TO THE PATIENT. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20727015 ↗MalfunctionNov 8, 2024Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ATTUNE FEMORAL TRIALS, RP TIBIAL IMPACTOR, SAW CAPTURE, SHIM AND FB TIBIAL IMPACTOR ARE BROKEN AND WORN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20645168 ↗MalfunctionOct 24, 2024Break; Break
IT WAS REPORTED THAT THE LEFT FEMORAL TRIAL BROKE IN HALF WHEN BEING INSERTED.
Patient problems: Insufficient Information
MAUDE report 20521323 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT FEMUR WAS FRACTURED WHILE TRIALING.
Patient problems: Insufficient Information
MAUDE report 20086307 ↗MalfunctionAug 13, 2024Break; Break
BROKEN CONSIGNED INSTRUMENTS NEEDING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977457 ↗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 19811473 ↗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 19811461 ↗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 19811438 ↗MalfunctionJun 21, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIALS WERE SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582037 ↗MalfunctionApr 10, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN AND WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081685 ↗
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