ARTICUL/EZE 2530-83-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295128960), received between Dec 13, 2017 and Oct 10, 2024 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (22 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 39 reports, in the reporter's own words as published by the FDA.

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

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT ONE OF THESE DRILLS WAS BROKEN INTO TWO PIECES, WHILE THE OTHER WAS BENT TO THE POINT OF UNUSABLE. NO PATIENT CONSEQUENCES RELATED TO ANY OF THESE MISSING DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421921 ↗
• MalfunctionJun 26, 2024Scratched Material; Scratched Material

  THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618047 ↗
• MalfunctionJun 26, 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 19616603 ↗
• 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 19132868 ↗
• 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 18434065 ↗
• 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 18434064 ↗
• 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 18343991 ↗
• 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 18236015 ↗
• 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 18181050 ↗
• 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 18181020 ↗
• 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-(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 PROPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177585 ↗
• 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 16817504 ↗
• 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 16817491 ↗
• 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 16817353 ↗
• MalfunctionJan 3, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085702 ↗
• MalfunctionJan 3, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085687 ↗
• MalfunctionJan 3, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085671 ↗
• 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 15588137 ↗
• 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 15588123 ↗
• 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 15443192 ↗
• 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 15065682 ↗
• 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 15065648 ↗
• 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 15065485 ↗
• 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 15065335 ↗
• 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 15065330 ↗