ATTUNE 2545-00-708Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL CRUCIATE RETAINING SIZE 8 RIGHT · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy ATTUNE femoral trial component, a size 8 right cruciate-retaining trial piece used to check fit during knee replacement surgery. The 76 reports mostly describe the trial breaking or cracking during surgery, along with scratches, worn surfaces, and markings worn off. There are no deaths and one injury. 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
- 77
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295133803), received between Sep 24, 2018 and Sep 10, 2026 — classified as 1 injury, 76 malfunctions.
The most frequently reported specific device problem is “Break” (51 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
- Break51
- Naturally Worn10
- Scratched Material9
- Crack7
- Illegible Information4
- Material Discolored4
- Material Deformation3
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient21
- No Code Available4
- Insufficient Information2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718062 ↗MalfunctionJun 2, 2026Break
IT WAS REPORTED THAT THE 8 RIGHT CR TRIAL BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364882 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED DURING TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2026 THE 8 CRUCIATE RETAINING TRAIL BROKE DURING TRAILING. BROKEN PIECE WAS RETRIEVED AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25254711 ↗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 24958444 ↗MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTUNE CR TRIAL FEMUR BROKE DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941797 ↗MalfunctionFeb 26, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. DID THE DEVICE BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN, OR CROSS THREADED? PLEASE EXPLAIN. NO BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456917 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT THE POSTERIOR CONDYLE OF THE SIZE 8 ATTUNE FEMORAL TRIAL BROKE WHILE ASSESSING THE PATIENT'S RANGE OF MOTION ¿ROM¿. ALL PIECES WERE RECOVERED AND THE SURGERY PROCEEDED WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232667 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23977677 ↗MalfunctionDec 17, 2025Break; Break
DURING THE CLEANING PROCESS, IT WAS INFORMED TO ME BY CENTRAL SUPPLY THAT THE (B)(6) FEMORAL TRIAL WAS BROKEN. IF OTHER, DESCRIBE --> NOT ASSOCIATED WITH ANY SURGERY, IF OTHER, DESCRIBE --> NOT ASSOCIATED WITH ANY SURGICAL, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NOT ASSOCIATED WITH ANY SURGERY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IF YES, DESCRIBE --> NOT ASSOCIATED WITH ANY SURGERY, IS THE PATIENT PART OF A CLINICAL STUDY --> DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827455 ↗MalfunctionOct 29, 2025Break; Break
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THEY WERE USING AN INSERVICE AND DISCOVERED THE IMPACTOR WAS CRACKED AND FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413617 ↗MalfunctionOct 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE FEMORAL TRIAL WARPED AND NOT FITTING CORRECTLY ON THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366746 ↗MalfunctionAug 7, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE REPORTED TO BE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22740679 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE CR TRIAL BROKE ON IMPACTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716507 ↗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 22201654 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THE ATTUNE FEMORAL TRIAL WAS BROKEN. THERE WAS A TWO MINUTE SURGICAL DELAY AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962036 ↗MalfunctionMar 18, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
DURING A RIGHT TOTAL KNEE REPLACEMENT, THE SURGEON INADVERTENTLY BROKE THE SIZE 8 RIGHT CR FEMORAL TRIAL WITH THE IMPACTOR. THERE WAS NO INORDINATE AMOUNT OF FORCE APPLIED AND THE SURGERY OTHERWISE PROCEEDED SMOOTHLY. NO SURGICAL DELAY. FRAGMENTS WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630065 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT THE ONE OF THE POSTERIOR SECTIONS OF THE ATTUNE CR SIZE 8 FEMORAL TRIAL BROKE OFF WHILE INSERTING. THE BROKEN FRAGMENT WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A 7 MINUTES OF SURGICAL DELAY. NEW SET OF EQUIPMENT WAS BROUGHT INTO THE OR AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306117 ↗MalfunctionJan 27, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL BROKE. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241832 ↗MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT THE RED KNOB BROKE OFF THE FEMORAL INTRODUCER. THE FEMORAL TRIAL BROKE INTO TWO PIECES. NO HARM WAS DONE TO PATIENT AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795193 ↗MalfunctionOct 23, 2024Break; Break
IT WAS REPORTED THAT THE ITEM HAS A CHIP OUT OF IT.
Patient problems: Insufficient Information
MAUDE report 20513265 ↗MalfunctionAug 13, 2024Break; Break
BROKEN CONSIGNED INSTRUMENTS NEEDING REPLACEMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977456 ↗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 19609518 ↗MalfunctionMay 2, 2024Break; Break
IT WAS REPORTED THAT DURING AN ATTEMPT TO TRIAL THE FEMORAL COMPONENT, THE SURGEON WENT TO PUT THE KNEE INTO EXTENSION AND THE POSTERIOR LATERAL CONDYLE OF THE TRIAL HAD BROKEN OFF. THE TRIAL BROKE IN TWO PIECES, BOTH WERE ABLE TO BE REMOVED FROM THE OPERATION AND REPLACED BY A SECOND TRIAL TO FINISH THE PROCEDURE. THERE WAS NO DELAY IN THE CASE AND THERE WAS NO HARM DONE TO THE PATIENT. NO FURTHER INFORMATION ON THIS SITUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19229069 ↗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 19171656 ↗MalfunctionMar 12, 2024Break; Break
IT WAS REPORTED THAT THE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18891626 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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