ARTICUL/EZE 2531-52-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE TRIAL HEAD 36mm +5 · 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 head is a sizing instrument used during hip surgery. The 226 reports mostly describe scratched or worn surfaces, parts breaking, and trial heads slipping off or not snapping onto neck trials. The reports include 2 injuries 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
- 226
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 10603295129196), received between Dec 28, 2017 and May 21, 2026 — classified as 2 injuries, 224 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (128 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
- Scratched Material128
- Naturally Worn72
- Break52
- Material Deformation25
- Material Twisted/Bent14
- Device-Device Incompatibility13
- Crack9
- Material Integrity Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions146
- No Consequences Or Impact To Patient67
- Insufficient Information12
- No Code Available4
- Foreign Body In Patient1
- Hip Fracture1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 226 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE HEAD TRIALS SLIP OFF NECK TRIALS DURING SURGERY. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241278 ↗MalfunctionMay 12, 2026Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED THAT HEAD TRIALS ARE DAMAGED AND UNABLE TO BE STERILIZED. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151303 ↗MalfunctionApr 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL HEAD WILL NOT SNAP ON NECK TRIAL. PLEASE SEND REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844900 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247170 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247167 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247164 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247162 ↗MalfunctionFeb 3, 2026Crack; Material Deformation
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24247122 ↗MalfunctionDec 31, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE, THE HEAD BALL GOT STUCK ON TRIAL NECK AND THE DRILL BIT BROKE. THERE WERE NO INJURIES OR DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933707 ↗MalfunctionJul 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED INSTRUMENTS WERE SCRATCHED AND TWISTED. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382331 ↗MalfunctionMar 3, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE HEAD TRIALS WERE STRIPPED AND WON'T STAY ON NECK. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21509472 ↗MalfunctionMar 3, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE HEAD TRIALS WERE STRIPPED AND WON'T STAY ON NECK. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21509318 ↗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 20623832 ↗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 20622547 ↗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 20622507 ↗MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE HEAD TRIALS WERE WORN, SCRATCHED AND CHIPPED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579002 ↗MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE HEAD TRIALS WERE WORN, SCRATCHED AND CHIPPED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578928 ↗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 20324539 ↗MalfunctionAug 26, 2024Break; Break
IT WAS REPORTED THAT THE 36+5 HEAD TRIAL WAS BROKEN. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20063941 ↗MalfunctionJul 26, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
STAFF HAVE INDICATED SEVERAL TRIAL FEMORAL HEADS ARE SCRATCHED AND WORN DUE TO WEAR AND TEAR/USAGE OVER TIME. THEY ARE NO LONGER USABLE AND REQUIRE REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19843439 ↗MalfunctionJun 28, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE SURGEONS WANT NEW TRIAL HEADS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633336 ↗MalfunctionJun 28, 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 19633326 ↗MalfunctionJun 28, 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 19633320 ↗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 19608217 ↗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 19608203 ↗
Other TEMPLATE devices
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- 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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