ATTUNE 2545-00-737Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 7 LEFT · 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 sizing tool used in knee replacement surgery. The FDA records hold 96 reports, with no deaths and no injuries; many describe the trial breaking or cracking during use or inspection, and some describe scratched surfaces. Many reports say there was no patient harm. 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
- 95
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 10603295134091), received between Jan 5, 2018 and May 19, 2026 — classified as 95 malfunctions.
The most frequently reported specific device problem is “Break” (48 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
- Break48
- Scratched Material25
- Crack17
- Naturally Worn9
- Appropriate Device Problem Term/Code Not Available5
- Material Twisted/Bent5
- Material Integrity Problem4
- Device-Device Incompatibility3
Patient problems
- No Consequences Or Impact To Patient46
- No Clinical Signs, Symptoms or Conditions43
- Insufficient Information6
- No Code Available1
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Break
IT WAS REPORTED THAT DURING OFFICE INSPECTION A FRACTURE WAS FOUND ON THE BACK PORTION OF FEMUR TRIALS. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222619 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THE TRIAL BROKE AS THE DOCTOR WAS IMPACTING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096841 ↗MalfunctionMar 30, 2026Break; Crack
IT WAS REPORTED THAT TRIALS WERE CRACKED OR BROKEN AND THE HOSPITAL WILL NOT ACCEPT THEM. THE ANGEL WING WAS BENT, AND THE TIBIA IMPACTOR HAS POPPED ITS SPRING. THE POLY LOST A SPRING ON ONE OF THE POSTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729980 ↗MalfunctionFeb 5, 2026Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT ATTUNE PS FEM TRIAL SZ 7 LT WAS SCRATCHED AND UNABLE TO ARTICULATE PROPERLY DURING A PROCEDURE. THE EVENT OCCURRED DURING A PROCEDURE, BUT THERE WAS NO ADVERSE OUTCOME OR CONSEQUENCE TO THE PATIENT, AND THE SURGERY WAS NOT PROLONGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268525 ↗MalfunctionNov 3, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450922 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438869 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435720 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THE FEMORAL TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435719 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT DEVICE WAS BROKEN DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290485 ↗MalfunctionJul 24, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND WITHIN A BROKEN INSTRUMENTS TUB AT HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588519 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: Insufficient Information
MAUDE report 22197453 ↗MalfunctionJan 28, 2025Break; Break
IT WAS REPORTED THAT SURGEON BROKE THE INSTRUMENT WHILE TRIALING.
Patient problems: Insufficient Information
MAUDE report 21255405 ↗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 21124855 ↗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 20137714 ↗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 20137711 ↗MalfunctionAug 28, 2024Break; Break
THE ATTUNE ARTICULAR SURFACE PEG ON THE UNDERSIDE OF THE INSTRUMENT BROKE OFF CLEANLY WHILE THE SURGEON WAS TRYING TO INSERT IT. ALL FRAGMENTS WERE RETRIEVED AND A DIFFERENT ARTICULAR SURFACE WAS QUICKLY USED WITHOUT ANY FURTHER ISSUES. THIS ONLY DELAYED THE SURGERY FOR A FEW MINUTES. SURGERY DELAYED 3 MINUTES DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20084837 ↗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 19807355 ↗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 19807352 ↗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 19807351 ↗MalfunctionApr 9, 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 19070026 ↗MalfunctionJan 23, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIAL HAS A NICK IN THE MATERIAL. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES , 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 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 18563186 ↗MalfunctionDec 7, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE.
Patient problems: Insufficient Information
MAUDE report 18282802 ↗MalfunctionDec 1, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED FROM SALES REP STATES THAT THERE WAS NO DELAY, PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18252104 ↗MalfunctionNov 15, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT BOTH FEMORAL TRIALS HAVE GIANT CRACKS IN THEM. ONE IS ON THE BOTTOM PART OF THE BOX AND THE OTHER IS AT THE TOP PORTION OF THE BOX. NEITHER INSTRUMENT BROKE INTO TWO PIECES. NOTHING WAS LEFT IN THE PATIENT. NO ADVERSE EFFECTS. NO TIME ADDED TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145944 ↗MalfunctionNov 15, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT BOTH FEMORAL TRIALS HAVE GIANT CRACKS IN THEM. ONE IS ON THE BOTTOM PART OF THE BOX AND THE OTHER IS AT THE TOP PORTION OF THE BOX. NEITHER INSTRUMENT BROKE INTO TWO PIECES. NOTHING WAS LEFT IN THE PATIENT. NO ADVERSE EFFECTS. NO TIME ADDED TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145943 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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