ARTICUL/EZE 2531-50-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10603295129172), received between Sep 8, 2017 and May 12, 2026 — classified as 1 injury, 86 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (43 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Contamination /Decontamination Problem; Material Integrity Problem

  IT WAS REPORTED THAT HEAD TRIALS ARE DAMAGED AND UNABLE TO BE STERILIZED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151378 ↗
• MalfunctionFeb 2, 2026Crack; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232733 ↗
• MalfunctionFeb 2, 2026Crack; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232724 ↗
• MalfunctionFeb 2, 2026Crack; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232559 ↗
• MalfunctionFeb 2, 2026Crack; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232555 ↗
• MalfunctionFeb 2, 2026Crack; Material Deformation

  IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232519 ↗
• MalfunctionOct 30, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE IMPACTED PRODUCT HAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427136 ↗
• MalfunctionMar 3, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE HEAD TRIALS WERE STRIPPED AND WON'T STAY ON NECK. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509476 ↗
• MalfunctionMar 3, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE HEAD TRIALS WERE STRIPPED AND WON'T STAY ON NECK. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509405 ↗
• MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578565 ↗
• MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEAD TRIALS ARE WORN, SCRATCHED AND CHIPPED. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578418 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  SURGEON AND OR STAFF NOTED THAT VARIOUS FEMORAL HEAD TRIALS IN HIP SETS ARE SCUFFED, GOUGED AND VISIBLY WORN. NEED REPLACEMENTS WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> TRIALS WERE USED ANYWAY AS THEY WERE STILL VIABLE FOR THE TIME BEING. , WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, 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, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (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 20552013 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  SURGEON AND OPERATING ROOM STAFF NOTED THAT VARIOUS FEMORAL HEAD TRIALS IN HIP SETS ARE SCUFFED, GOUGED AND VISIBLY WORN. NEED REPLACEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544570 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEADS WERE SCRATCHED AND BEAT UP.

  Patient problems: Insufficient Information

  MAUDE report 20543533 ↗
• MalfunctionAug 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS WANT NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931409 ↗
• MalfunctionAug 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS WANT NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931331 ↗
• MalfunctionJul 26, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  STAFF HAVE INDICATED SEVERAL TRIAL FEMORAL HEADS ARE SCRATCHED AND WORN DUE TO WEAR AND TEAR/USAGE OVER TIME. THEY ARE NO LONGER USABLE AND REQUIRE REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19843553 ↗
• MalfunctionApr 18, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEADS WERE WORN AND SCRATCHED.

  Patient problems: Insufficient Information

  MAUDE report 19132845 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT DURING IMPACTION, SMALL PLASTIC RESIDUES ARE VISIBLE IN THE PROXIMAL ZONE OF THE FEMUR. IT DOES NOT CAUSE ANY INCONVENIENCE EXCEPT THE SURGEON MUST REMOVE THE SMALL FRAGMENTS THAT ARE RELEASED FROM THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992975 ↗
• MalfunctionFeb 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT SURGEON COMPLAINED ABOUT HEADS SHEDDING AND WANTED TO REPLACE THOSE WITH THE NEW STYLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684747 ↗
• MalfunctionFeb 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT SURGEON COMPLAINED ABOUT HEADS SHEDDING AND WANTED TO REPLACE THOSE WITH THE NEW STYLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684746 ↗
• MalfunctionFeb 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT SURGEON COMPLAINED ABOUT HEADS SHEDDING AND WANTED TO REPLACE THOSE WITH THE NEW STYLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684744 ↗
• MalfunctionFeb 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT SURGEON COMPLAINED ABOUT HEADS SHEDDING AND WANTED TO REPLACE THOSE WITH THE NEW STYLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684559 ↗
• MalfunctionFeb 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TRIAL HEADS AS THEY WERE WORN AND NOT SUITABLE FOR SURGERY. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? NO, 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, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 INFORMATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651679 ↗
• MalfunctionFeb 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TRIAL HEADS AS THEY WERE WORN AND NOT SUITABLE FOR SURGERY. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? -- NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? NO, 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, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 INFORMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651672 ↗