ATTUNE 2545-00-726Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 6 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 has 122 adverse event reports, with no deaths or injuries. Most reports describe the trial breaking, cracking, or scratching during impaction, trialing, or processing, and most say no patient was affected. 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
- 122
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10603295133988), received between Sep 5, 2017 and Aug 17, 2026 — classified as 122 malfunctions.
The most frequently reported specific device problem is “Break” (59 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
- Break59
- Scratched Material30
- Crack23
- Naturally Worn8
- Appropriate Device Problem Term/Code Not Available5
- Adverse Event Without Identified Device or Use Problem3
- Contamination /Decontamination Problem3
- Device-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Consequences Or Impact To Patient47
- Insufficient Information5
- No Information2
Recent adverse event reports
The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50274297 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT TWO ATTUNE DEVICES WERE BROKEN DURING PROCESSING AND NOT DURING SURGERY. NO PATIENTS WERE AFFECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244229 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE FEMORAL TRIAL WAS BROKEN DURING TRIALING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092314 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT THE REPORTED DEVICE WAS BROKEN DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698180 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE THE POSTERIOR CONDYLE OF THE TRIAL BROKE OFF UPON IMPACTION. THE EVENT WAS MANAGED BY OPENING A NEW SET. THERE WAS A 4 MINUTES OF SURGICAL DELAY, BUT THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24569564 ↗MalfunctionMar 6, 2026Contamination /Decontamination Problem
IT WAS REPORTED THE CEMENT WAS STUCK TO THE FEMORAL TRIAL AND COULD NOT BE STERILIZED BY THE STERILE PROCESSING DEPARTMENT (SPD). ALL PARTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534888 ↗MalfunctionJan 7, 2026Break
IT WAS REPORTED THAT THE FEMUR TRIAL BROKE DURING IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991458 ↗MalfunctionNov 10, 2025Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT BOTH FEMUR TRIALS BROKE DURING TRIALING, REQUIRING THE OPENING OF A THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511977 ↗MalfunctionNov 10, 2025Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT BOTH FEMUR TRIALS BROKE DURING TRIALING, REQUIRING THE OPENING OF A THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511972 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438874 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438872 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435856 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025. THE FEMORAL TRIAL BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964056 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: Insufficient Information
MAUDE report 22197159 ↗MalfunctionMay 30, 2025Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE ATTUNE CR FEMORAL TRIAL, CAUSING STERILIZATION ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113086 ↗MalfunctionFeb 7, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL AND FEMORAL IMPACTOR BROKE.
Patient problems: Insufficient Information
MAUDE report 21337438 ↗MalfunctionJan 10, 2025Material Discolored; Illegible Information; Material Discolored; Illegible Information
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SALES REP WAS NOT SURE WHEN THE ISSUE OCCURRED BUT HE MENTIONED THAT IT WAS NOTICED DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124684 ↗MalfunctionSep 18, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKE AND NEEDING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20247288 ↗MalfunctionSep 13, 2024Break; Break
IT WAS REPORTED THAT DURING IMPACTION FOR TRAILING BOTH FEMURS BROKE/SPLIT.
Patient problems: Insufficient Information
MAUDE report 20212433 ↗MalfunctionSep 13, 2024Break; Break
IT WAS REPORTED THAT DURING IMPACTION FOR TRAILING BOTH FEMURS BROKE/SPLIT.
Patient problems: Insufficient Information
MAUDE report 20212385 ↗MalfunctionSep 4, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137710 ↗MalfunctionSep 4, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137706 ↗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 19806285 ↗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 19806240 ↗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 19806082 ↗
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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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