ATTUNE 2545-00-727Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 7 RIGHT · 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 tool used during knee replacement. Its 99 adverse event reports include no deaths, 1 injury and 98 malfunctions. The reports mostly describe the trial breaking, cracking or being scratched, and a few describe pieces breaking off during surgery. Reports fell to 2 in the last 12 months from 10 in the year before. 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
- 99
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10603295133995), received between Jun 30, 2017 and Mar 20, 2026 — classified as 1 injury, 98 malfunctions.
The most frequently reported specific device problem is “Break” (43 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
- Break43
- Scratched Material27
- Crack26
- Naturally Worn12
- Appropriate Device Problem Term/Code Not Available4
- Material Deformation4
- Contamination /Decontamination Problem3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- No Consequences Or Impact To Patient38
- Insufficient Information4
- No Code Available2
- Bone Fracture(s)1
- No Information1
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2026. THE FEMUR TRIAL BROKE DURING TRIALING PHASE OF THE CASE. THERE WAS NO INJURIES OR DELAYS DURING THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649601 ↗MalfunctionDec 15, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, BEFORE STARTING THE SURGERY, EQUIPMENT IS UNCOVERED AND IT IS EVIDENT THAT THE HOHMANN SEPARATOR WAS BENT, IN ADDITION IT IS OBSERVED THAT THE TIBIA IMPACTOR WAS SPLIT AND THE FEMORAL COMPONENT 7 RIGHT TEST WAS ALSO SPLIT. FOR THESE NOVELTIES THERE WAS NO DISCOMFORT OF THE SPECIALIST SINCE ALTHOUGH THESE REFERENCES PRESENT QUITE REMARKABLE NOVELTIES IT WAS POSSIBLE TO USE THEM, THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTATIONS OF THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809890 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438890 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438831 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438819 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435895 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22197236 ↗MalfunctionMar 21, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL BROKE DURING THE CASE. THE SURGEON WAS ATTEMPTING TO SEAT THE TRIAL, A PIECE OF THE TRIAL BROKE OFF. THE SURGERY WAS NOT DELAYED. THE ITEM WAS REMOVED FROM THE OPERATION SITE, ANOTHER SET WAS OPENED AND THE SAME SIZE TRIAL FEMUR USED TO COMPLETE THE TRIAL. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663732 ↗InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON REALIZED THE LATERAL CONDOLE WAS FRACTURED AFTER TRIALING PS IMPLANTS. THE TRIAL WAS PLACED ON PREPARED FEMUR AND IMPACTED TO SEAT ON DISTAL FEMUR. FRACTURE WAS FIXED WITH 4.5MM SCREW AND IMPLANTS WERE CEMENTED INTO PLACE. NO SURGICAL DELAY.
Patient problems: Bone Fracture(s)
MAUDE report 21295061 ↗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 21124859 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL BROKE DURING IMPACTING. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21111739 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL FRACTURED WHILE IMPACTING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21061317 ↗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 20138031 ↗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 20137977 ↗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 19807027 ↗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 19806876 ↗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 19806823 ↗MalfunctionJul 3, 2024Break; Naturally Worn; Break; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED BECAUSE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19666500 ↗MalfunctionJul 3, 2024Break; Naturally Worn; Break; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED BECAUSE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19666479 ↗MalfunctionJul 3, 2024Break; Naturally Worn; Break; Naturally Worn
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED BECAUSE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19666478 ↗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 19171704 ↗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 19081659 ↗MalfunctionApr 1, 2024Naturally Worn; Naturally Worn
EDGES ARE STRIPPED AND CAN NO LONGER BE USED. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19010957 ↗MalfunctionMar 21, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIALS HAD SIGNIFICANT SCRATCHES/GOUGES. MAINLY SIZE 6 AND 7 TRIALS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY NO, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18951744 ↗MalfunctionFeb 26, 2024Break; Crack; Break; Crack
ATTUNE PS FEM TRIAL SZ 7 RT IS CRACKED AND CHIPPED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778154 ↗
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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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