AML EXCEL 2001-49-000Recalls & reported problems
Depuy (Ireland) · AML EXCEL CALCAR MILL LARGE · Class 1
Quick summary
This DePuy AML Excel calcar mill, a hip surgery tool for shaping bone, has 212 adverse event reports, with no deaths and 2 injuries. Most describe the tool failing to cut bone during hip replacement surgery, and most list no symptoms in the patient. 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
- 212
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 10603295080022), received between May 21, 2018 and Oct 16, 2025 — classified as 2 injuries, 210 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (205 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 Cut205
- Material Deformation6
- Illegible Information4
- Dull, Blunt3
- Break2
- Device-Device Incompatibility2
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions184
- Insufficient Information20
- No Consequences Or Impact To Patient5
- Limb Fracture2
- No Code Available2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 212 reports, in the reporter's own words as published by the FDA.
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 23312509 ↗MalfunctionJan 14, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PLANER DOES NOT CUT ANYMORE, IT DOES NOT WORK. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21151432 ↗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 20589864 ↗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 20589815 ↗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 20589604 ↗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 20589594 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL (SMALL, MEDIUM, AND LARGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539878 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL (SMALL, MEDIUM, AND LARGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539080 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL (SMALL, MEDIUM, AND LARGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537319 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL (SMALL, MEDIUM, AND LARGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20537005 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL (SMALL, MEDIUM, AND LARGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535604 ↗MalfunctionOct 25, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL (SMALL, MEDIUM, AND LARGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535216 ↗MalfunctionOct 11, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ACTIS CALCAR REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20433431 ↗MalfunctionOct 11, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ACTIS CALCAR REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20432296 ↗MalfunctionOct 11, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ACTIS CALCAR REAMERS ARE DULL. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431699 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS DULLING DRILL BITS COILS LOOSENING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20262536 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS DULLING DRILL BITS COILS LOOSENING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20261980 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS DULLING DRILL BITS COILS LOOSENING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20261721 ↗MalfunctionSep 19, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS DULLING DRILL BITS COILS LOOSENING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20260956 ↗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 20063669 ↗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 20063666 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: Insufficient Information
MAUDE report 19962710 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS ARE DULL.
Patient problems: Insufficient Information
MAUDE report 19962695 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: Insufficient Information
MAUDE report 19959809 ↗MalfunctionAug 12, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL.
Patient problems: Insufficient Information
MAUDE report 19959806 ↗
Other Bone mill devices
- AML EXCEL 2001-48-000Depuy (Ireland) · Bone mill472 reports
- AML EXCEL 2001-47-000Depuy (Ireland) · Bone mill220 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.