AML EXCEL 2001-47-000Recalls & reported problems
Depuy (Ireland) · AML EXCEL CALCAR MILL SMALL · Class 1
Quick summary
This DePuy AML Excel calcar mill is a surgical tool used to shape bone during hip replacement. Most of its 220 reports describe the mill failing to cut bone well, and some describe dull or broken parts. No injuries or deaths were reported. 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
- 220
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 10603295080008), received between Jan 16, 2019 and Mar 26, 2026 — classified as 220 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (210 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut210
- Material Deformation6
- Dull, Blunt5
- Illegible Information5
- Break3
- Device-Device Incompatibility2
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions185
- Insufficient Information27
- No Consequences Or Impact To Patient6
- Not Applicable2
- No Code Available1
Recent adverse event reports
The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT BROKEN ITEMS FROM ACTIS CORE TRAY WERE NOTED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699817 ↗MalfunctionOct 16, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR MILL NOT SHARP ENOUGH TO REAM AWAY BONE. NO DELAYS, NOTHING LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312507 ↗MalfunctionNov 1, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, PLANER DISCS WERE UNABLE TO PROVIDE PROPER REAMING OF THE FEMUR AND CREATED CUSTOMER DISSATISFACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589646 ↗MalfunctionNov 1, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED, THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, PLANER DISCS WERE UNABLE TO PROVIDE PROPER REAMING OF THE FEMUR. AND CREATED CUSTOMER DISSATISFACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589601 ↗MalfunctionNov 1, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, PLANER DISCS WERE UNABLE TO PROVIDE PROPER REAMING OF THE FEMUR AND CREATED CUSTOMER DISSATISFACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589593 ↗MalfunctionNov 1, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, PLANER DISCS WERE UNABLE TO PROVIDE PROPER REAMING OF THE FEMUR AND CREATED CUSTOMER DISSATISFACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20589592 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539949 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539206 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539164 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539132 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539100 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536817 ↗MalfunctionOct 23, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
ADDITIONAL INFORMATION RECEIVED AND STATING THAT: A. WHAT WAS THE EXACT ALLEGATION AGAINST THE PRODUCT? - IT WAS JUST SPINNING ON THE BONE. B. WAS THERE ANY SURGICAL DELAY? - YES, WE HAD TO OPEN ANOTHER INSTRUMENT SET TO GET A NEW ONE. C. WAS THERE ANY PATIENT HARM REPORTED? - NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517772 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258254 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258233 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258181 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20258048 ↗MalfunctionSep 5, 2024Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PRODUCT IS WORN.
Patient problems: Insufficient Information
MAUDE report 20152476 ↗MalfunctionAug 26, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SMALL CALCAR PLANAR WAS TOO DULL. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064520 ↗MalfunctionAug 26, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL AND DAMAGED TO POINT OF DIFFICULTY SCREWING INTO LEADING TO SURGEON BECOMING UNPLEASED. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20063674 ↗MalfunctionAug 26, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL AND DAMAGED TO POINT OF DIFFICULTY SCREWING INTO LEADING TO SURGEON BECOMING UNPLEASED. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20063673 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: Insufficient Information
MAUDE report 19962718 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: Insufficient Information
MAUDE report 19962692 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: Insufficient Information
MAUDE report 19962679 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: Insufficient Information
MAUDE report 19962674 ↗
Other Bone mill devices
- AML EXCEL 2001-48-000Depuy (Ireland) · Bone mill472 reports
- AML EXCEL 2001-49-000Depuy (Ireland) · Bone mill212 reports
- SUMMIT 2570-04-100Depuy (Ireland) · Bone mill193 reports
- SUMMIT 2570-04-200Depuy (Ireland) · Bone mill91 reports
- NA L94010Depuy (Ireland) · Bone mill22 reports
- LPS 2987-70-001Depuy (Ireland) · Bone mill5 reports
- NA 4861-00-010Depuy (Ireland) · Bone mill4 reports
- NA 2001-80-503Depuy Orthopaedics, Inc. · Bone mill3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.