ARTICUL/EZE 2531-53-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE TRIAL HEAD 36mm +8.5 · Class 1
All models of ARTICUL/EZE (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ARTICUL/EZE trial head is a surgical instrument used during hip replacement. Many of the 136 reports describe instruments scratched, cracked or worn out, and some mention trial heads that would not stay on the neck. There are no deaths and 1 injury. 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
- 136
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 10603295129202), received between Dec 13, 2017 and Feb 3, 2026 — classified as 1 injury, 135 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (82 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material82
- Naturally Worn49
- Break25
- Material Deformation18
- Material Twisted/Bent9
- Crack8
- Device-Device Incompatibility8
- Peeled/Delaminated7
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- No Consequences Or Impact To Patient38
- Insufficient Information5
- No Code Available3
- Bone Fracture(s)1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.
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 24247437 ↗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 24247436 ↗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 24247177 ↗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 24247173 ↗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 24247115 ↗MalfunctionDec 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE HIP REPLACEMENT PROCEDURE, THE 32+9 TRIAL HEAD WAS FOUND TO BE BADLY SCRATCHED AND WORN. THERE WERE NO BROKEN PIECES, NO DELAYS, AND NO COMPLICATIONS FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708366 ↗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 21509437 ↗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 21509401 ↗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 20624434 ↗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 20623770 ↗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 20578977 ↗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 20551144 ↗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 20550603 ↗MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE SURGEON AND OPERATING ROOM STAFF NOTED THAT VARIOUS FEMORAL HEAD TRIALS IN THE HIP SETS ARE SCUFFED, GOUGED AND VISIBLY WORN. THE TRIALS WERE USED ANYWAY AS THEY WERE STILL VIABLE AT THAT TIME. THERE WERE NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20546109 ↗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 19843433 ↗MalfunctionJul 2, 2024Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE DURING THE CASE.
Patient problems: Insufficient Information
MAUDE report 19656138 ↗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 19633356 ↗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 19633330 ↗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 19633327 ↗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 19633319 ↗MalfunctionMay 16, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE SURGEON COMPLAINED THE TRIAL HEADS WERE SCRATCHED AND PLASTIC WAS COMING OFF.
Patient problems: Insufficient Information
MAUDE report 19330010 ↗MalfunctionMay 16, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE SURGEON COMPLAINED THE TRIAL HEADS WERE SCRATCHED AND PLASTIC WAS COMING OFF.
Patient problems: Insufficient Information
MAUDE report 19329975 ↗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 19132666 ↗MalfunctionFeb 26, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL IS NICKED/SCRATCHED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: 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. 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 18777828 ↗MalfunctionFeb 16, 2024Scratched Material; Scratched Material
ROUTINE INSPECTION HEAD TRAILS WITH SCRAPES AND GAUGES OUT OF THEM IN NEED OF REPLACEMENT. IT WAS REPORTED THAT THE HEAD TRIALS ARE SCRATCHED/GOUGED. 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. (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. 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 18727186 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page