ARTICUL/EZE 2530-94-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE TRIAL BALL GROOVED 32mm DIA +13 · Class 1
All models of ARTICUL/EZE (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ARTICUL/EZE trial femoral head is a grooved trial ball used during hip replacement surgery. The 43 reports mostly describe the head wearing down, getting scratched, and breaking, including one report of it breaking into several pieces during surgery, though the fragments were removed easily and surgery finished as planned; one injury was reported and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295129028), received between Dec 13, 2017 and Mar 30, 2026 — classified as 1 injury, 42 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (21 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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn21
- Scratched Material16
- Break11
- Peeled/Delaminated6
- Material Twisted/Bent4
- No Apparent Adverse Event4
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient7
- Bone Fracture(s)1
- Insufficient Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Break
IT WAS REPORTED THAT THE HEAD OF THE ARTIC/EZE TR BALL GRVD 32+13 BROKE INTO SEVERAL PIECES DURING TOTAL HIP REPLACEMENT SURGERY. SURGERY WAS NOT DELAYED. FRAGMENTS WERE DISCARDED IN THE SHARPS BIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24716211 ↗MalfunctionNov 6, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE HEADS ARE SCRATCHED AND NEED REPLACED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622905 ↗MalfunctionJul 1, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT SURGEONS WANT NEW EMPHASYS HEADS. IT DID NOT HAPPEN IN SURGERY. ADDITIONAL INFORMATION: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE OUTER SURFACE OF THE DEVICE PRESENTS SINGS OF WEAR AND DISCOLORATION CONSISTENT WITH REPEATED USE AND SERVICING FOR ALONG PERIOD OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19644498 ↗MalfunctionJun 25, 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 19607768 ↗MalfunctionJun 25, 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 19607749 ↗MalfunctionJun 25, 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 19607530 ↗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 19132844 ↗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 18686718 ↗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 18686717 ↗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 18686713 ↗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 18686708 ↗MalfunctionNov 30, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
COMPLAINT IS RELATED TO (B)(4). THIS COMPLAINT WAS CREATED DUE TO THE EXCESS IMPACTED PRODUCTS IN (B)(4). DAMAGED PLASTIC FEMORAL HEAD TRIALS - NEED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236071 ↗MalfunctionNov 30, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
COMPLAINT IS RELATED TO (B)(4) . THIS COMPLAINT WAS CREATED DUE TO THE EXCESS IMPACTED PRODUCTS IN (B)(4) . DAMAGED PLASTIC FEMORAL HEAD TRIALS - NEED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236047 ↗MalfunctionNov 30, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED AND STATED: A. WHAT WAS SPECIFICALLY THE DAMAGE ON THE DEVICES (BROKEN (2+ PIECES), CRACKED, BENT, STRIPPED/WORN). THE HEAD TRIALS HAVE BEEN SCRATCHED / WORN. PLASTIC IS DAMAGED. B. CAN YOU PLEASE PROVIDE THE LOT NO OF THE REPORTED PRODUCTS? WORKING WITH OPERATIONS ON THE SWAP OUT, LOT NUMBERS AVAILABLE ON RETURN OF TRIALS. C. WHAT IS THE EVENT DATE? WORN OVER TIME, EVENT DATE IS AS PER REPORT DATE. D. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO- IDENTIFIED OUTSIDE SURGERY. E. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236045 ↗MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD IS WORN, SCRATCHED AND POSSIBLY SHEDDING PLASTIC SHARDS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18178128 ↗MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD IS WORN, SCRATCHED AND POSSIBLY SHEDDING PLASTIC SHARDS. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18178095 ↗MalfunctionNov 20, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE FEMORAL TRIAL HEAD IS WORN, SCRATCHED AND POSSIBLY SHEDDING PLASTIC SHARDS. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18178015 ↗MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN AND THE PLASTIC WAS FLAKING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16323528 ↗MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn
IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN AND THE PLASTIC WAS FLAKING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16323495 ↗MalfunctionDec 14, 2022Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
DURING THE TRIAL REDUCTION IT WAS NOTICED THAT ALL THE 32MM TRIAL HEADS HAD GOUGES AND WEAR MARKS ON THEM, THE 32MM IMPACTOR ALSO HAD ONE SMALL GOUGE AS WELL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15983759 ↗MalfunctionOct 7, 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 15566971 ↗MalfunctionOct 7, 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 15562511 ↗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 15443193 ↗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 15069698 ↗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 15069147 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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