ATTUNE 2545-00-591Recalls & reported problems
Depuy (Ireland) · ATTUNE RP TRIAL POST · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE trial post is an instrument used during knee replacement surgery. The 33 reports mostly describe trial posts breaking or chipping, with wear, scratches, deformation, and occasional loss during sterile processing; there were no deaths or injuries. No recalls name this device. Reports fell from 6 in the previous 12 months to 0 in the latest 12 months.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295133223), received between Sep 12, 2017 and Aug 13, 2025 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (28 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
- Break28
- Device-Device Incompatibility6
- Naturally Worn4
- Scratched Material2
- Detachment of Device or Device Component1
- Material Deformation1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information5
- No Consequences Or Impact To Patient5
- No Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22796987 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL POSTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608448 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL POSTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608433 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL POSTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608403 ↗MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PLASTIC TRIAL POST WAS LOST GOING THROUGH STERILE PROCESSING AFTER A TOTAL KNEE REPLACEMENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902642 ↗MalfunctionJan 27, 2025Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT ATTUNE RP TRIAL POST WAS SHOWING SIGNS OF WEAR. IT HAD MANY GOUGES AND CHIPS AROUND THE INSTRUMENT. SURGERY TIME WAS NOT EXTENDED AND THERE WERE NO MISSING PIECES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241532 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE RP TRIAL POSTS ARE CHIPPED.
Patient problems: Insufficient Information
MAUDE report 19703665 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE RP TRIAL POSTS ARE CHIPPED.
Patient problems: Insufficient Information
MAUDE report 19703663 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE RP TRIAL POSTS ARE CHIPPED.
Patient problems: Insufficient Information
MAUDE report 19703199 ↗MalfunctionJul 9, 2024Break; Break
IT WAS REPORTED THAT THE RP TRIAL POSTS ARE CHIPPED.
Patient problems: Insufficient Information
MAUDE report 19703020 ↗MalfunctionMar 26, 2024Break; Break
IT WAS REPORTED THAT THE PINS ARE STUCK IN TIBIAL CUTTING BLOCK. THE AUGMENT NO LONGER FITS INTO TRIAL. THE RP TRIAL POST IS BROKEN. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 18977420 ↗MalfunctionFeb 21, 2024Break; Break
IT WAS REPORTED THAT THE RP TRIAL POST STUCK IN THE TIBIA, REMOVED WITH RONGEUR AND BROKEN AT THE TIP. SURGEON DISPOSED REQUESTED A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18747843 ↗MalfunctionSep 29, 2023Break; Break
IT WAS REPORTED THAT THE RP TRIAL POST WAS DAMAGED WITH A RONGEUR WHILE TRYING TO REMOVE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17844606 ↗MalfunctionJul 14, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT RP TRIAL POSTS OLD AND CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325864 ↗MalfunctionJul 14, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT RP TRIAL POSTS OLD AND CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325862 ↗MalfunctionJul 14, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT RP TRIAL POSTS OLD AND CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325845 ↗MalfunctionMay 5, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE RP TRIAL POST STUCK IN THE TIBIA AND REMOVED WITH THE RONGUER. THE POST WAS CHEWED OFF. ALL THE PIECES WERE RECOVERED AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16878271 ↗MalfunctionMay 5, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE DEVICE WAS MISSING WHEN ASSEMBLING AFTER THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16876221 ↗MalfunctionMar 29, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE RP TRIAL POST WAS STUCK IN THE RP TIBIAL AFTER TRIAL AND WAS THEN GRAB BY A RONGEUR TO REMOVE AND THE TOP PORTION OF THE INSTRUMENT WAS CUT OFF.ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16636327 ↗MalfunctionMar 22, 2023Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT A NICK IN THE POST WAS CATCHING ON THE SHIM MAKING IT DIFFICULT TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16590612 ↗MalfunctionMar 15, 2023Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16550695 ↗MalfunctionNov 18, 2022Break; Break
PATIENT WAS REVISED DUE TO TOTAL KNEE. RP TRIAL POST BROKE DURING SURGERY. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15824907 ↗MalfunctionOct 7, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON THOUGHT THE WHITE POST WAS SITTING A LITTLE HIGH. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15562669 ↗MalfunctionMar 29, 2022Break; Break
THE PLASTIC IS CHIPPED ON THE INSTRUMENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13940773 ↗MalfunctionDec 1, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
THE POST WAS MISSHAPED AT THE TOP AND NOT HOLDING TRIALS. THE PIN DRIVER WAS NOT ALLOWING PINS TO COME OFF EASILY, 6/8 DRILL STOP WAS NOT STAYING ON THE DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12912569 ↗
Other TEMPLATE devices
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- 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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