ARTICUL/EZE 2530-84-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295128977), received between Dec 13, 2017 and Oct 10, 2024 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (16 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 28 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 20420636 ↗
• 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 19132862 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THIS CASE IS LINKED TO (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS - NEED REPLACEMENT PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434365 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THIS CASE IS LINKED TO (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS - NEED REPLACEMENT PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434074 ↗
• MalfunctionJan 3, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THIS CASE IS LINKED TO (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS NEED REPLACEMENT. PLASTIC IS WORN AND SCRATCHED ON HEAD TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434068 ↗
• 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 18343972 ↗
• MalfunctionNov 21, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD HAS DAMAGED PLASTIC POSSIBLY SHEDDING PLASTIC SHARDS. NO PATIENT CONSEQUENCE. 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 18181054 ↗
• MalfunctionNov 21, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD HAS DAMAGED PLASTIC POSSIBLY SHEDDING PLASTIC SHARDS. NO PATIENT CONSEQUENCE. 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 (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4) , DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4) , DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4) , DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4) , DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180985 ↗
• MalfunctionNov 21, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD HAS DAMAGED PLASTIC POSSIBLY SHEDDING PLASTIC SHARDS. NO PATIENT CONSEQUENCE. 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 NON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180981 ↗
• 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 16817517 ↗
• 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 16817508 ↗
• 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 16817410 ↗
• 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 15588239 ↗
• 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 15588181 ↗
• 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 15443190 ↗
• 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 15069568 ↗
• 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 15065615 ↗
• 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 15065543 ↗
• 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 15065432 ↗
• 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 15065265 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT THE SKIRT PLASTIC PART ON THE 28MM HEAD TRIAL CRACKED AND BROKE OFF INTO TWO PIECES. ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994449 ↗
• MalfunctionNov 2, 2021Defective Device; Defective Device

  TRIAL HEADS ARE NOT THE RIGHT 12/14 TAPER, ONE IS SMALLER AND ONE IS OVERSIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739004 ↗
• MalfunctionSep 22, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT 49 AND 56 REAMER ARE DULL AND NOT CUTTING. CALCAR REAMER AND SHAFT ARE CROSS THREADED. THE BOX OSTEOTOME IS BENT AT THE TIP AND 28 MM HEADS ARE FADED AND THE NUMBERS CANT BE READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517172 ↗
• MalfunctionMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED FOR UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404522 ↗
• MalfunctionDec 6, 2019Crack; Material Discolored; Material Twisted/Bent; Crack; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT THE DURALOC STR CUP IMPACTOR - THREADS DAMAGED. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. ARTIC/EZE TR BALL GRVD 28+5 - TRIAL FADED, CRACKED AND WORN. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. ARTIC/EZE TR BALL GRVD 28+12 - TRIAL FADED, CRACKED AND WORN. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9424032 ↗