AML EXCEL 2001-65-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10603295080121), received between May 3, 2018 and Aug 7, 2026 — classified as 137 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (52 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174654 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT WHITE IMPACTOR TIP BROKE DURING HEAD IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821636 ↗
• MalfunctionMar 5, 2026Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE DEVICES WERE DESCRIBED AS CHEWED UP AND REQUIRING REPLACEMENT. THE EVENT DID NOT RESULT IN ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520215 ↗
• MalfunctionFeb 5, 2026Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE TIP IMPACTOR IS UNEVEN AND PLASTIC IS CUT UP. THE DOCTOR REQUESTED IT BE REPLACED DUE TO POTENTIAL HEAD DAMAGE. NOTHING LEFT IN PATIENT. NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272123 ↗
• MalfunctionJan 14, 2026Break

  THE POLY HAS BROKEN OFF. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071773 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT HEAD IMPACTOR TIP WAS OLD AND PEELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993249 ↗
• MalfunctionDec 30, 2025Break; Break

  DURING A PTH TODAY, WE BROKE A D55MM TEST CUP REF: (B)(4) AS WELL AS THE WHITE TIP OF THE FEMORAL IMPACTOR. WE HAD AN ISSUE BECAUSE THE TRIAL CUP BECAME LODGED IN THE PATIENT. WE HAD TO ATTEMPT MANY MANEUVERS TO REMOVE IT, WHICH CAUSED THE DAMAGE TO THE TWO PARTS. WE EVENTUALLY SUCCEEDED USING EQUIPMENT AVAILABLE AT THE FACILITY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927156 ↗
• MalfunctionDec 23, 2025Material Deformation; Material Deformation

  DURING ROUTINE MEDICAL DEVICE REPROCESSING STAFF NOTICED THE THREADS OF THIS IMPACTOR HEAD WERE STRIPPED AND NO LONGER FUNCTIONAL. PLEASE REPLACE, THANK YOU CUSTOMER REFERENCE/PO/SERVICE:PO TO FOLLOW, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877098 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT DURING SET UP, PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THE INSTRUMENTS WERE BROKEN. IT WAS THE FIRST USE OF THE SET. ANOTHER SET WAS USED TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO DELAY TO SURGERY OR PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810297 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING SURGERY. IT WAS REPORTED THAT THERE WAS NO NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810091 ↗
• MalfunctionSep 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE IMPACTOR HANDLE¿S THREADS, ON THE END GOT BENT. IT WAS NOTICED WHEN REASSEMBLING SET. THE THREADS ARE DAMAGE IN SUCH A WAY THAT THE POLY TIP CAN¿T BE SCREWED ON. NEEDS TO BE REPLACED. NO DELAY IN SURGERY AS THIS WAS NOTICE WHILE REASSEMBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050541 ↗
• MalfunctionAug 7, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT THE IMPACTOR WAS RECEIVED WITH EXISTING DAMAGE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741675 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED IMPACTOR WAS BROKEN. THERE WAS NO DELAY TO SURGERY OR PATIENT EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729265 ↗
• MalfunctionJul 30, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, IT WAS NOTED THAT THE PLASTIC THREAD ON THE HEAD PUSHER HAD BEEN DAMAGED AND THE PUSHER IS NOT SEATING DOWN ON THE METAL ATTACHMENT AS IT SHOULD. SURGERY WAS NOT DELAYED DUE TO THE EVENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665750 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT THE HUMERAL HEAD IMPACTOR WHITE HEAD ONLY DAMAGED WHEN CLEANING INSTRUMENT, THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564168 ↗
• MalfunctionJul 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DURING DEVICE REPROCESSING, STAFF NOTICED DEFECTS ON EQUIPMENT THAT PREVENTED THEM FROM BEING SAFE TO USE FOR PATIENTS. THE FEMORAL RASP WAS MISSING TEETH, THE CALCAR MILLS WERE DULL, THE FEMORAL HEAD IMPACTOR WAS CROSS THREADED AND THE CURVED BROACH HANDLE DID NOT CLOSE PROPERLY. NO PATIENT CONSEQUENCES. (B)(4) IS RELATED TO (B)(4) WHICH WAS CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554527 ↗
• MalfunctionJul 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DURING DEVICE REPROCESSING, STAFF NOTICED DEFECTS ON EQUIPMENT THAT PREVENTED THEM FROM BEING SAFE TO USE FOR PATIENTS. THE FEMORAL RASP WAS MISSING TEETH, THE CALCAR MILLS WERE DULL, THE FEMORAL HEAD IMPACTOR WAS CROSS THREADED AND THE CURVED BROACH HANDLE DID NOT CLOSE PROPERLY. NO PATIENT CONSEQUENCES. (B)(4) IS RELATED TO (B)(4) WHICH WAS CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554151 ↗
• MalfunctionJun 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE IMPACTOR TIP ARE COMPLETELY STRIPPED. EXTRACTOR TIP IS COMPLETELY BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286362 ↗
• MalfunctionMay 9, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE HEAD IMPACTOR ARE STRIPPED AND WON'T THREAD ON ALL THE WAY TO THE HANDLE. THERE WAS NO REAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21997192 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT CENTRAL STERILE STAFF IDENTIFIED FEMORAL HEAD IMPACTORS WITH DAMAGED TIPS, FEMORAL CANAL PROBE WITH DAMAGED FLUTES WITH THE POTENTIAL TO PRODUCE METAL BURRS, AND PLASTIC TRIAL COMPONENTS WITH DEEP GROOVES AND DAMAGE. THIS DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552824 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. B. CAN YOU PLEASE CLARIFY WHAT YOU MEAN BY "DAMAGED"? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED, OR ANY DEVICE INTERACTION? WORN, BENT, AND SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551111 ↗
• MalfunctionOct 15, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE FEMORAL HEAD IMPACTOR WAS WORN AND MISSHAPED. PATIENT IMPACT ¿ NONE ¿ ABLE TO FINISH OPERATION HOWEVER VERY WORN AND REQUIRING REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20450525 ↗
• MalfunctionSep 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED ON SEPTEMBER 4, 2024 THAT THE FEMORAL/HUMERAL HEAD IMPACTOR IS STRIPPED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235742 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT THE PLASTIC HEAD IMPACTOR TIP IS CHIPPED OFF AND BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199873 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT HEAD IMPACTOR HANDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20156022 ↗