ATTUNE 2545-00-728Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 8 RIGHT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE size 8 right posterior-stabilized femoral trial post is a disposable plastic template surgeons use to size and position knee implants during total knee replacement surgery. The 61 reports mostly describe trials breaking, cracking or scratching during surgery — often while being inserted or struck — along with bent or deformed parts and worn-out markers; several mention fragments retrieved with no harm to the patient. There are no deaths and no injuries, and 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
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295134008), received between Aug 28, 2017 and Jun 11, 2026 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Scratched Material17
- Crack12
- Naturally Worn8
- Material Twisted/Bent4
- Contamination /Decontamination Problem2
- Device-Device Incompatibility2
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient29
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information3
- No Information1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THERE WERE BROKEN CONSIGNMENTS SIZE 7 PS RP ARTICULATING SURFACE TRIAL, SIZE 5 PS RP ARTICULATING SURFACE TRIAL, AND RIGHT FEMORAL TRIAL PS SIZE 8 FROM PS NOTCH SIZE 3-5 TRAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477843 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY THE FEMUR TRIAL BROKE DURING IMPACTING. NOTHING WAS LEFT IN THE PATIENT. THERE WERE NO DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205321 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT FEMUR TRIAL CRACKED WHILE THE DOCTOR WAS INSERTING IT. NO DELAYS RECORDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957507 ↗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 24730731 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435877 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: Insufficient Information
MAUDE report 22197316 ↗MalfunctionJan 16, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THERE WAS CRACK IN TRIAL. A REPLACEMENT WAS AVAILABLE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY AND NO EFFECT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21168879 ↗MalfunctionSep 4, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE TRIAL WAS WORN OUT AND THE COLOR MARKING WERE PARTIALLY FADED. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140655 ↗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 20137989 ↗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 19806953 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806158 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806045 ↗MalfunctionJul 23, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN WHILE IMPACTING. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19804355 ↗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 19171701 ↗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 17071688 ↗MalfunctionMar 7, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16497090 ↗MalfunctionFeb 22, 2023Break; Break
THE PRODUCT WAS REPORTED DUE TO AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16423278 ↗MalfunctionDec 5, 2022Crack; Naturally Worn; Crack; Naturally Worn
IT WAS REPORTED THAT SALES CONSULTANT HAS 2 FEMORAL TRIALS THAT ARE CRACKED. CENTRAL STERILE IS WANTING THEM REPLACED. HE WAS RETURNING FOR INSPECTION, AVERAGE WEAR AND TEAR. THIS DID NOT DELAY A SURGERY. NO ONE WAS INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15916289 ↗MalfunctionJul 19, 2022Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT THE ATTUNE FEMORAL TRIALS ARE SCRATCHED AND BANGED UP TO THE POINT WHERE STERILIZATION IS AN ISSUE. NO IMPACT TO PATIENT. DATE OF EVENT (B)(6) 2022. NO DELAYS TO CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15053144 ↗MalfunctionOct 5, 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 12578406 ↗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 12557593 ↗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 12557579 ↗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 12557531 ↗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 12557486 ↗MalfunctionSep 7, 2021Crack; Crack
HOSPITAL STAFF NOTICING CRACKINE INSPECTION. NO SURGICAL DELAYLS DURING ROUTINE INSPECTION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12433029 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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