ARTICUL/EZE 2531-51-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE TRIAL HEAD 36mm +1.5 · 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, a surgical sizing part, has 323 reports, including 3 injuries and no deaths. Many describe scratched, worn, cracked or broken parts, with some reports of trial heads slipping off their necks. 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
- 323
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 10603295129189), received between Aug 25, 2017 and May 21, 2026 — classified as 3 injuries, 320 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (168 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 Material168
- Naturally Worn102
- Break73
- Material Deformation42
- Material Twisted/Bent25
- Device-Device Incompatibility18
- Peeled/Delaminated16
- Material Integrity Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions213
- No Consequences Or Impact To Patient93
- Insufficient Information14
- No Code Available7
- No Information3
- Bone Fracture(s)1
- Not Applicable1
- Pain1
Recent adverse event reports
The 25 most recent of 323 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 25241673 ↗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 25241275 ↗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 24247147 ↗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 24247113 ↗MalfunctionFeb 2, 2026Crack; Material Deformation
IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233068 ↗MalfunctionFeb 2, 2026Crack; Material Deformation
IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232927 ↗MalfunctionFeb 2, 2026Crack; Material Deformation
IT WAS REPORTED SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232653 ↗MalfunctionDec 12, 2025Break; Break
PIECES BREAKING OFF THE HEAD BALL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? PICKED OUT THE PIECES OF THE PLASTIC. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. 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. 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 23794399 ↗MalfunctionNov 25, 2025Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT HIP HEAD TRIAL WAS SCRATCHED AND WAS LEAVING DEBRIS IN PATIENT. ALL PIECES REMOVED AND CASE PROCEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646563 ↗MalfunctionNov 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 36+1.5 HEAD TRIAL WOULD NOT STAY ON THE NECK TRIAL. PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570708 ↗MalfunctionOct 10, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY ONE (1) FRAGMENT FROM THE 36MM HEAD TRIAL CHIPPED OFF DURING TRAILING, THE FRAGMENT WAS REMOVED AND NO OTHER FRAGMENTS WERE GENERATED. NO DELAY TO SURGERY AND SURGERY WAS COMPLETED. NO KNOWN COMPLICATIONS OR PATIENT ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23267720 ↗MalfunctionJul 16, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT IN A HIP REPLACEMENT, THE HEAD AND NECK TRIAL BECAME DISSOCIATED. THE HEAD WAS LOST FOR A FEW MINUTES.
Patient problems: Insufficient Information
MAUDE report 22518399 ↗MalfunctionJun 12, 2025Break; Break
IT WAS REPORTED THERE WERE MULTIPLE BROKEN DEVICES.
Patient problems: Insufficient Information
MAUDE report 22197209 ↗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 21509482 ↗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 21509322 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A MISSING PINNACLE VERSION GUIDE. FRAGMENTS WERE MADE BY THE FEMORAL HEAD TRIAL; THEY WERE EASILY REMOVED. THE HEAD TRIAL IS WORN AND NEEDED REPLACING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216752 ↗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 20622889 ↗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 20622499 ↗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 20622444 ↗MalfunctionNov 1, 2024Break; Break
INSTRUMENT BROKE DURING SURGERY AT HOSPITAL. THE INSTRUMENT IS CHIPPED- NO PIECES WERE LEFT INSIDE THE PATIENT, THERE WAS NO DELAY TO SURGERY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20585942 ↗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 20579150 ↗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 20579130 ↗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 20578922 ↗MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
SURGEON AND OR STAFF NOTED THAT VARIOUS FEMORAL HEAD TRIALS IN HIP SETS ARE SCUFFED, GOUGED AND VISIBLY WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20552701 ↗MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
SURGEON AND OR STAFF NOTED THAT VARIOUS FEMORAL HEAD TRIALS IN HIP SETS ARE SCUFFED, GOUGED AND VISIBLY WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20552220 ↗
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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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