ARTICUL/EZE 2530-82-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295128953), received between Jul 13, 2017 and Oct 10, 2024 — classified as 1 injury, 51 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (24 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT NO SURGICAL DELAY FOR ANY OF THESE REPORTED DEVICES, HOWEVER, TIME IS REQUIRED TO ORDER LOANER SETS WHILE WAITING FOR MISSING ITEMS TO BE RESTOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20422209 ↗
• MalfunctionSep 27, 2024Scratched Material; Scratched Material

  IT WAS REPORTED ON AUGUST 20, 2024 THAT ALL ITEMS ARE SCRATCHED DUE TO REPEATED USE. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327271 ↗
• MalfunctionJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS REQUESTED NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND SIGNS OF WORN OUT AT THE ARTIC/EZE TR BALL GRVD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567191 ↗
• MalfunctionJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS REQUESTED NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND SIGNS OF WORN OUT AT THE ARTIC/EZE TR BALL GRVD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567189 ↗
• MalfunctionJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS REQUESTED NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567178 ↗
• MalfunctionJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS REQUESTED NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND SIGNS OF WORN OUT AT THE ARTIC/EZE TR BALL GRVD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567176 ↗
• MalfunctionJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT SURGEONS REQUESTED NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND SIGNS OF WORN OUT AT THE ARTIC/EZE TR BALL GRVD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567172 ↗
• 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 19132871 ↗
• MalfunctionDec 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HEADS HAVE BEEN WORN DOWN OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343954 ↗
• MalfunctionNov 30, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS SPECIFICALLY THE DAMAGE ON THE DEVICES (BROKEN (2+ PIECES), CRACKED, BENT, STRIPPED/WORN). PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS. B. CAN YOU PLEASE PROVIDE THE LOT NO OF THE REPORTED PRODUCTS? WORKING WITH OPS TO SWAP OUT, LOT NUMBERS WILL. BE AVAILABLE ON RETURN OF TRIAL HEADS. C. WHAT IS THE EVENT DATE? AS REPORTED BY THE PC- HEADS HAVE BEEN WORN OVER TIME WITH USE. D. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. E. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO, IDENTIFIED OUTSIDE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236018 ↗
• MalfunctionNov 30, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE PLASTIC FEMORAL HEAD TRIALS ARE DAMAGED AND NEED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236016 ↗
• MalfunctionNov 30, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE PLASTIC FEMORAL HEAD TRIALS ARE DAMAGED AND NEED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236014 ↗
• MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT TRIAL HEAD IS WORN OUT AND POSSIBLY SHEDDING PLASTIC SHARDS. 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. (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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177542 ↗
• MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT TRIAL HEAD IS WORN OUT AND POSSIBLY SHEDDING PLASTIC SHARDS. 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. (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? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177445 ↗
• MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT TRIAL HEAD IS WORN OUT AND POSSIBLY SHEDDING PLASTIC SHARDS. 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. (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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177406 ↗
• MalfunctionNov 16, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE HEAD IS SCRATCHED AND FLAKING. SURGEON WORRIED IT MAY DAMAGE THE POLY WHEN TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148129 ↗
• MalfunctionApr 26, 2023Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE ARTIC/EZE TRAIL HEADS WERE CHIPPED AND THE COLORS ARE FADED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817477 ↗
• MalfunctionApr 26, 2023Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE ARTIC/EZE TRAIL HEADS WERE CHIPPED AND THE COLORS ARE FADED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817448 ↗
• MalfunctionApr 26, 2023Break; Material Discolored; Break; Material Discolored

  IT WAS REPORTED THAT THE ARTIC/EZE TRAIL HEADS WERE CHIPPED AND THE COLORS ARE FADED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817336 ↗
• MalfunctionFeb 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  TOTAL HIP REPLACEMENT. HEAD TRIAL WAS LOOSE WHEN PLACED ON STEM TRUNION, CAME OFF WHILST TRIALING. OPENED NEW INSTRUMENT SET AND NEW HEAD TRIAL WAS STABLE. 1 MINUTE DELAY TO SURGERY. CONSIGNMENT SET, NOT SURE WHAT THE ZZ CODE IS AS THEY HAVE PUT THEM IN SEPARATE GREEN TRAYS.

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

  MAUDE report 16303353 ↗
• MalfunctionOct 12, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE OLD AND SCRATCHED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588144 ↗
• MalfunctionOct 12, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEADS ARE OLD AND SCRATCHED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588116 ↗
• MalfunctionSep 17, 2022Illegible Information; Illegible Information

  ALL OF THE NUMBERS ARE NOT VISIBLE TO THE STAFF AS THEY HAVE RUBBED OFF. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443194 ↗
• MalfunctionJul 20, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065717 ↗
• MalfunctionJul 20, 2022Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT ITEM WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065671 ↗