ATTUNE 2545-00-715Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 5 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 is a size 5 left trial piece used to test fit during knee replacement surgery. The 69 reports mostly describe the plastic trial breaking, cracking, chipping or wearing during surgery or cleaning and sterilization, with scratches and discoloration also noted. No deaths and no injuries were reported; fragments were recovered in the cases described, with little or no added operating time. Reports fell from 10 in the prior 12 months to 5 in the latest. 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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10603295133872), received between Jul 11, 2017 and Feb 26, 2026 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Break” (39 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
- Break39
- Scratched Material17
- Naturally Worn12
- Crack7
- Material Deformation6
- Illegible Information4
- Material Discolored4
- Material Twisted/Bent4
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Consequences Or Impact To Patient17
- Insufficient Information3
- No Code Available3
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION PROCESSES IT WAS OBSERVED THAT DEVICES EXHIBIT DAMAGE AND WEAR IN THE CONDYLE AREA. IN ADDITION CHIPS AND SCRATCHES ARE ALSO VISIBLE IN THE DEVICE PHOTOS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456924 ↗MalfunctionFeb 3, 2026Break
IT WAS REPORTED THAT ATTUNE FEMORAL TRIAL SIZE 5 LEFT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244834 ↗MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE ATTUNE CR FEM TRIAL WAS BROKEN IN HALF DURING IMPACTION. ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189704 ↗MalfunctionDec 22, 2025Break; Break
10 MINS ADDED ON TO OPERATION WHILE THEY GOT A NEW TRAY SPRING IS DAMAGED ON ARTIC SURF CHIPPED OF LEFT SIDE OF FEMORAL TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862592 ↗MalfunctionNov 4, 2025Break; Break
IT WAS REPORTED THAT THE LATERAL CONSOLE OF THE TRIAL COMPONENT SNAPPED WHILE TRIALING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465707 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, THE TRIAL COMPONENT BROKE. THERE WERE NO PATIENT CONSEQUENCES. THE SURGICAL TEAM OPENED A NEW SET AND TRAILED AGAIN. THE PROCEDURE WAS PROLONGED BY THREE MINUTES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424279 ↗MalfunctionJul 1, 2025Crack; Crack
IT WAS REPORTED THAT THE 5 CR TRIAL HAS VISIBLE CRACKS IN IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371838 ↗MalfunctionJun 10, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE FEMORAL TRIAL CONDYLE BROKE INTO TWO PIECES WHILE MOVING LEG FROM FLEXION TO EXTENSION. SURGERY WAS EXTENDED BY ONE MINUTE DUE TO THE EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22174637 ↗MalfunctionMay 16, 2025Crack; Crack
IT WAS REPORTED THAT FEMORAL TRIAL CRACKED WHILE IMPACTING.
Patient problems: Insufficient Information
MAUDE report 22039467 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT LATERAL CONDYLE BROKE OFF DURING IMPACTION. THERE WERE NO ADVERSE CONSEQUENCES AND NO SURGICAL DELAY. ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708233 ↗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 21654834 ↗MalfunctionMar 14, 2025Break; Break
IT WAS REPORTED THAT WHILE IMPACTING THE FEMORAL TRIAL, THE ITEM BROKE INTO TWO PIECES. NOTHING WAS LEFT BEHIND. THERE WAS LESS THAN A MINUTE OF ADDITIONAL TIME ADDED TO SURGERY IN ORDER TO OPEN A NEW TRAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604665 ↗MalfunctionFeb 20, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE ATTUNE CR FEMORAL COMPONENT BROKE INTO TWO PIECES WHEN IMPACTED WITH THE FEMORAL IMPACTOR INTRA-OPERATIVELY. BOTH PIECES WERE RETRIEVED. NO FRAGMENTS WERE GENERATED. PROCEDURE COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21421609 ↗MalfunctionDec 9, 2024Break; Break
IT WAS REPORTED THAT THE SIZE 5 LEFT CR TRIAL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20885744 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED, THAT THE SURGEON WAS IMPACTING TRIAL WHEN IT BROKE IN 2 PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858326 ↗MalfunctionOct 15, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS A BROKEN AND WORN PINNACLE 32MM +4/10 DEGREE LINER TRIAL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451803 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LEFT FEMUR SIZE 5 IN CR TRIAL BROKE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440025 ↗MalfunctionOct 14, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO DELAY, NO ADVERSE CONSEQUENCES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20439660 ↗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 19609430 ↗MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED THAT THE KNEE TRIALS WERE DAMAGED. IT WAS UNABLE TO USE. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458073 ↗MalfunctionApr 24, 2024Break; Crack; Break; Crack
ADDITIONAL INFORMATION WAS RECEIVED: -WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO. -WERE THE BROKEN FRAGMENTS RETAINED IN THE PATIENT? (YES OR NO): NO. -PLEASE STATE WHICH DEVICE BROKE IN 2 TO ENSURE NOT ALL 15 ARE CODED FOR BROKEN IF REMAINING DEVICES ARE ONLY CRACKED. THIS WILL IMPACT REPORTABILITY TO THE HEALTH AUTHORITY AT DAY 15 SO IT IS URGENT. ONE HAS BEEN BROKEN BUT WE DO NOT KNOW WHICH ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171625 ↗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 19171607 ↗MalfunctionMar 27, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO REPORTS OF SURGICAL DELAY AND PATIENT HARM. THE DEVICE WAS ALSO CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18985898 ↗MalfunctionMar 8, 2024Break; Material Deformation; Break; Material Deformation
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. 4. 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.? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865329 ↗MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT THE TRAY CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552590 ↗
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
- 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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