ARTICUL/EZE 2530-81-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10603295128946), received between Jul 13, 2017 and Oct 10, 2024 — classified as 1 injury, 56 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (26 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 57 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 20423082 ↗
• 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 19567190 ↗
• 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 19567177 ↗
• 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 19567173 ↗
• 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 19567171 ↗
• 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 19567170 ↗
• 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 19132877 ↗
• 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 18343928 ↗
• 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 18236017 ↗
• 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 18235995 ↗
• 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 18235993 ↗
• 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, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177441 ↗
• 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: NON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177310 ↗
• 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, IP-01894239 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894240 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894241 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894242 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894243 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894244 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894245 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894246 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894247 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894248 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894249 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894250 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-01894251 DEVICE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177273 ↗
• MalfunctionOct 19, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE 28 HEAD BROKE INTO TWO PIECES. THERE WAS A SUTURE THAT WAS RUN THROUGH THE SUTURE HOLES ON THE HEAD AND THE HOLE PIECE BETWEEN THE SUTURE HOLES BROKE OFF. THE FRAGMENT WAS RETRIEVED. NO ADVERSE CONSEQUENCES AFFECTED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965969 ↗
• MalfunctionMay 31, 2023Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT DEVICE WAS SCUFFED, SCRAPED, GOUGED AND DENTED A NUMEROUS LOCATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031651 ↗
• 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 16817436 ↗
• 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 16817430 ↗
• 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 16817308 ↗
• MalfunctionOct 12, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THERE WERE NO PIECES BROKEN OFF FROM THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588129 ↗
• 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 15588110 ↗
• 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 15443188 ↗
• 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 15065656 ↗
• 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 15065482 ↗
• 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 15065455 ↗