AML EXCEL 2001-48-000Recalls & reported problems
Depuy (Ireland) · AML EXCEL CALCAR MILL MEDIUM · Class 1
Quick summary
This DePuy AML Excel calcar mill is a surgical instrument used to shape bone during hip replacement surgery. Most of its 472 reports describe the mill failing to cut bone or being dull, with others mentioning worn, broken or scratched parts. The reports include 2 injuries and no deaths, and reports in the last 12 months fell to 1 from 13 before. 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
- 472
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 472 adverse event reports that list this exact device (DI 10603295080015), received between Sep 5, 2018 and Jun 1, 2026 — classified as 2 injuries, 470 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (416 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 Cut416
- Dull, Blunt37
- Naturally Worn14
- Material Deformation13
- Break12
- Contamination /Decontamination Problem5
- Illegible Information5
- Scratched Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions371
- Insufficient Information69
- No Consequences Or Impact To Patient41
- No Code Available5
- Limb Fracture2
- Not Applicable2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 472 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Failure to Cut
IT WAS REPORTED THAT SURGEON SAID THAT THE CALCAR PLANAR WAS DULL AND DID NOT CUT BONE. THEY ASKED IT TO BE REMOVED FROM THE HOSPITAL AND REPLACED. THERE WAS NO NEGATIVE OUTCOMES AND NO ISSUES TO PATIENT. THERE WAS NO ISSUES TO SURGEON AND NO DELAY OF SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349006 ↗MalfunctionOct 27, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR BLADE WASN¿T CUTTING BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393934 ↗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 23312508 ↗MalfunctionJul 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE PRODUCTS WERE EITHER SCRATCHED TOO BADLY OR DULL/WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22544197 ↗MalfunctionJul 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE PRODUCTS WERE EITHER SCRATCHED TOO BADLY OR DULL/WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22544194 ↗MalfunctionJul 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT, AND THE PRODUCTS WERE EITHER SCRATCHED TOO BADLY OR DULL/WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22544189 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178772 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178733 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178715 ↗MalfunctionJan 17, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178689 ↗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 20589649 ↗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 20589595 ↗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 20589591 ↗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 20589588 ↗MalfunctionOct 31, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SURGEON HAD 2 SPECIALS TRAYS WITH CALCAR PLANERS. BOTH MEDIUMS WERE DULL. A LARGE WAS USED WITH NO PROBLEMS. NO ADVERSE AFFECTS WITH PROCEDURE AND NO SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20582702 ↗MalfunctionOct 31, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SURGEON HAD 2 SPECIALS TRAYS WITH CALCAR PLANERS. BOTH MEDIUMS WERE DULL. A LARGE WAS USED WITH NO PROBLEMS. NO ADVERSE AFFECTS WITH PROCEDURE AND NO SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20582645 ↗MalfunctionOct 31, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE MEDIUM CALCAR PLANAR IS DULL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20579748 ↗MalfunctionOct 31, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE PLANAR WAS DULL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20577686 ↗MalfunctionOct 28, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE CALCAR BLADE BECAME DULL AFTER CONSISTENT USE. IT IS NO LONGER REMOVING BONE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547503 ↗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 20539906 ↗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 20539658 ↗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 20539448 ↗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 20538027 ↗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 20537200 ↗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 20535852 ↗
Other Bone mill devices
- AML EXCEL 2001-47-000Depuy (Ireland) · Bone mill220 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.