ATTUNE 2545-00-717Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 7 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 implant is a metal sizing template used during knee replacement surgery to fit the real implant. Most of its 58 reports describe the metal trial breaking, chipping or cracking during trialing and impact, plus surface wear, scratching and discoloration; the rest note no patient symptoms. There are no deaths and no injuries. No recalls name this device, and reports in the last 12 months have dropped from 8 to 2.
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
- 58
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295133896), received between Oct 9, 2018 and Jan 27, 2026 — classified as 58 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break31
- Naturally Worn10
- Scratched Material10
- Crack7
- Peeled/Delaminated5
- Illegible Information4
- Material Discolored4
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Consequences Or Impact To Patient9
- Insufficient Information4
- No Code Available2
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT CHIPPED FEMORAL TRIALS AND CHIPPED FEMORAL IMPACTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189088 ↗MalfunctionNov 12, 2025Break; Break
IT WAS REPORTED THAT FEMUR TRIAL CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536365 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THAT THE POSTERIOR CHONDYLE BROKE WHILE TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064067 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22337987 ↗MalfunctionJun 9, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY WHEN BEING IMPACTED TO TRIAL. SURGERY WAS NOT DELAYED AND WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THE MAIN PART OF THE INSTRUMENT SPLIT WITH IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22166182 ↗MalfunctionApr 4, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN SIZE 7 LEFT CR FEMUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774062 ↗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 21654826 ↗MalfunctionFeb 10, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE DURING TRIALING.
Patient problems: Insufficient Information
MAUDE report 21350033 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE CR FEMUR TRIAL HAS A CHIP IN THE NOTCH. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21304723 ↗MalfunctionJan 6, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY?- NO 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO 3. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? - YES, ONE OF THE POSTERIOR FEET BROKE OFF.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21083472 ↗MalfunctionAug 13, 2024Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS REQUIRING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19974741 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE. SURGICAL DELAY IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19704065 ↗MalfunctionJun 25, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIALS ALL HAVE SCRATCHES AND KNICKS OUT THE PLASTIC. HOSPITAL WILL NOT ALLOW THEM TO BE USED IN CASES. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19609450 ↗MalfunctionApr 24, 2024Break; Crack; Break; Crack
AT A GENERAL CHECK OF THE FEMORAL TRIAL, CRACKS WERE DISCOVERED IN THE SULCUS PART OF THE CS FEMORAL TRIALS AND CRACKS ON THE ANTERIOR SIDE OF THE BOX IN HET PS FEMORAL TRIALS. THE CRACKS CAN BE SEEN BY PUTTING TENSION ON THE TRIALS. AFTER INSPECTION WITH STRESS TEST ONE FEMORAL TRIAL BROKE IN TWO. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171712 ↗MalfunctionApr 24, 2024Break; Crack; Break; Crack
AT A GENERAL CHECK OF THE FEMORAL TRIAL, CRACKS WERE DISCOVERED IN THE SULCUS PART OF THE CS FEMORAL TRIALS AND CRACKS ON THE ANTERIOR SIDE OF THE BOX IN HET PS FEMORAL TRIALS. THE CRACKS CAN BE SEEN BY PUTTING TENSION ON THE TRIALS. AFTER INSPECTION WITH STRESS TEST ONE FEMORAL TRIAL BROKE IN TWO. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171710 ↗MalfunctionFeb 27, 2024Crack; Naturally Worn; Scratched Material; Crack; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE FEMUR TRIAL HAS BIG CUTS IN IT. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18787822 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT THE TRAY CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552618 ↗MalfunctionJan 18, 2024Break; Break
ONE OF THE CONDYLARS HAS SNAPPED OFF, IT HAS BROKEN IN TO 2 PIECES. NO ADVERSE REACTION TO PATIENT AND NO ADDED TIME TO PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18539998 ↗MalfunctionJan 16, 2024Scratched Material; Illegible Information; Scratched Material; Illegible Information
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DAMAGE WAS NOTICED DURING CLEANING SO POST-SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18518920 ↗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 18291802 ↗MalfunctionNov 27, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT ON THE FEMUR TRIALS IS CHIPPING. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209740 ↗MalfunctionNov 22, 2023Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18192090 ↗MalfunctionNov 16, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY ALLEGED DEFICIENCY IN THE REPORTED DEVICES? IF YES, PLEASE PROVIDE DETAILS. IS IT BROKEN, BENT, CRACKED, STRIPPED, WORN OR CROSS-THREADED? WORN. B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? THE PATIENT WAS NOT AFFECTED. C. SALES REP CONFIRMED TWO (2) TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18148143 ↗MalfunctionNov 14, 2023Material Deformation; Scratched Material; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED FOR SCRATCH/DENTS. THEY WERE CONSIDERED UNACCEPTABLE BY THE STERILE PROCESSING DEPARTMENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18134898 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT DEVICE BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861545 ↗
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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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