ARTICUL/EZE 2531-54-000Recalls & reported problems
Depuy (Ireland) · ARTICUL/EZE TRIAL HEAD 36mm +12 · 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 surgical instrument used to try different hip implant sizes during joint replacement surgery. The 52 reports mostly describe wear and damage to the instrument over time — scratched and worn surfaces, chipped or cracked parts, and heads that strip and no longer stay on the neck, with no patient harm reported. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295129219), received between Dec 13, 2017 and Feb 3, 2026 — classified as 1 injury, 51 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (23 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 Material23
- Naturally Worn16
- Break9
- Material Deformation9
- No Apparent Adverse Event7
- Peeled/Delaminated6
- Crack5
- Device-Device Incompatibility4
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient13
- No Code Available2
- Bone Fracture(s)1
- Insufficient Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 52 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 24247671 ↗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 24247670 ↗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 24247446 ↗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 24247444 ↗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 24247441 ↗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 21509423 ↗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 21509409 ↗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 20578926 ↗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 19633333 ↗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 19633332 ↗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 19633321 ↗MalfunctionJun 27, 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 19629359 ↗MalfunctionJun 27, 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 19629333 ↗MalfunctionJun 27, 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 19629219 ↗MalfunctionJun 27, 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 19629211 ↗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 19132665 ↗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 18686376 ↗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 18685865 ↗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 18685850 ↗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 18685842 ↗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 18434691 ↗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 18434682 ↗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 18434654 ↗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 18178374 ↗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 18178361 ↗
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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