ATTUNE 2545-00-729Recalls & reported problems
Depuy (Ireland) · ATTUNE FEMORAL TRIAL POSTERIOR STABLIZED SIZE 9 RIGHT · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295134015), received between Oct 23, 2019 and Jun 11, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Scratched Material3
- Material Integrity Problem2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2025Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025. AFTER THE PROCEDURE, THE TRIAL FEMUR SIZE 9 WAS IDENTIFIED BY CSSD AS BEING DAMAGED (SAW MARKS AND DIATHERMY BURNS AND WAS DEEMED NOT USABLE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22184187 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973848 ↗MalfunctionJan 18, 2023Break; Break
IT WAS REPORTED THAT THE FEMORAL TRIAL HAS A CHIP IN THE ANTERIOR FLANGE AND SPD SAID IT CAN NOT BE USED. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16194600 ↗MalfunctionDec 8, 2022Break; Break
IT WAS REPORTED THAT INSTRUMENT BROKE DURING KNEE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15943311 ↗MalfunctionNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DEVICE WAS RECEIVED AS A BLIND UNIT. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12881909 ↗MalfunctionAug 26, 2021Break; Break
IT WAS REPORTED THAT THE FEMUR TRIAL FRACTURED DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12370560 ↗MalfunctionJul 29, 2021Break; Break
IT WAS REPORTED THAT THE SIZE 9 RIGHT PS RIGHT TRIAL ANTERIOR CRACKED OFF WHILE IMPACTING ONTO THE FEMUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12247659 ↗MalfunctionApr 21, 2020Material Integrity Problem; Scratched Material; Material Integrity Problem; Scratched Material
IT WAS REPORTED THAT THE TRIALS ARE DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9982171 ↗MalfunctionMar 18, 2020Crack; Crack
IT WAS REPORTED THAT DURING INSPECTION OF SETS THAT THE INSTRUMENTS WERE FOUND CRACKED AND ONE HAD A CUT IN IT. NO FURTHER INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9848281 ↗MalfunctionDec 11, 2019Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE 9 RIGHT ATTUNE FEMORAL TRIAL FOUND DAMAGED WITH SAW BLADE AND CANNOT BE RESTERILIZED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9452868 ↗MalfunctionOct 23, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT THE SHIM AND FEMUR FOUND TO HAVE GOUGES AND SURFACE DAMAGE IN POST CLEANING INSPECTION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226208 ↗
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
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- 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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