ATTUNE 2545-00-738Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 8 LEFT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy Attune femoral trial post, a sizing instrument used during knee replacement surgery to check fit before implanting the real parts. The 56 reports mostly describe wear and damage found during cleaning and inspection: scratched surfaces, cracks and broken pieces, bent wings and popped springs, with the instrument sometimes no longer able to be sterilized. No deaths or injuries are reported. There are no recalls naming 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
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10603295134107), received between Oct 10, 2017 and Jun 16, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Break” (22 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
- Break22
- Scratched Material19
- Crack6
- Naturally Worn6
- Appropriate Device Problem Term/Code Not Available3
- Material Deformation3
- Material Integrity Problem3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Consequences Or Impact To Patient27
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information4
- No Information1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS WERE SCRATCHED FROM EVERYDAY WEAR AND TEAR AND WERE DEEMED UNABLE TO BE STERILIZED BY THE STERILE PROCESSING MANAGER. THIS DID NOT OCCUR DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25521676 ↗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 24729866 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT THE ATTUNE PS FEM TRIAL WAS BROKEN DURING TRIALING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377574 ↗MalfunctionNov 19, 2025Break; Break
IT WAS REPORTED THAT FEMUR BROKE DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597662 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: Insufficient Information
MAUDE report 22197594 ↗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 20138109 ↗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 20138102 ↗MalfunctionAug 28, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
INSTRUMENTS HAVE GOUGE MARKS AND CHIPS FROM WEAR AND TEAR. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20089506 ↗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 19807642 ↗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 19807626 ↗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 19807340 ↗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 19171697 ↗MalfunctionOct 19, 2023Crack; Crack
IT WAS REPORTED THAT LATTUNE PS FEM TRIAL SZ 8 LT CRACKED ON IMPACTION NO. PHOTO INVESTIGATION REVEALED FOREIGN SUBSTANCE DEPOSITION INSIDE THE CRACKED PART AS WELL. NO IMPACT ON PATIENT SURGERY SUCCESSFULLY COMPLETED 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: -- 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 17965434 ↗MalfunctionAug 25, 2023Break; Break
IT WAS REPORTED THAT AN ATTUNE PS FEM TRIAL SZ 8 LT BROKE DURING SURGERY. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17626918 ↗MalfunctionJun 6, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THERE ARE BLACK SPOTS ALL OVER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17071633 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 5 OF EACH SIDE FOR A TOTAL OF 30 REPLACEMENTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557423 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 5 OF EACH SIDE FOR A TOTAL OF 30 REPLACEMENTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557350 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 5 OF EACH SIDE FOR A TOTAL OF 30 REPLACEMENTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557346 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 5 OF EACH SIDE FOR A TOTAL OF 30 REPLACEMENTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557297 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ALL ATTUNE FEMORAL TRIALS HAVE FRACTURED FROM REPEATED IMPACTION. 5 OF EACH SIDE FOR A TOTAL OF 30 REPLACEMENTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557176 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICED CRACKS ON THE NOTCHES OF THE FEMORAL TRIALS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12433027 ↗MalfunctionJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165980 ↗MalfunctionJun 15, 2021Break; Break
IT WAS REPORTED THAT A FEMORAL INTRODUCER AND 8 LEFT PS TRIAL BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12002798 ↗MalfunctionMay 14, 2021Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE NOTCH GUIDES HAVE ALL LOST THE WHITE ON THE NUMBERS AND ALSO HAVE WEAR/GROOVES ON THE METAL SURFACES. THE FEMORAL TRIALS ARE DISCOLORED AND HAVE GOUGES ON THE SURFACE. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826029 ↗MalfunctionFeb 3, 2021Crack; Crack
IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT DISCOVERED CUTS AND CRACKS ON THE FEMORAL TRIALS. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11273077 ↗
Other TEMPLATE devices
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- 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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