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ARTICUL/EZE 2530-91-000Recalls & reported problems

Depuy (Ireland) · ARTICUL/EZE TRIAL BALL GROOVED 32mm DIA +1 · 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 ball appears in 265 adverse event reports, with no deaths and 3 injuries. The reports mostly describe scratched, worn or chipped trial heads, with some pieces breaking off and occasional doubt about the correct size. Many reports note no patient consequences. 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
271
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 10603295128991), received between Dec 4, 2017 and Sep 18, 2026 — classified as 3 injuries, 268 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (173 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

Nov 2023: 6 reportsDec 2023: 1 reportsJan 2024: 2 reportsFeb 2024: 9 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 3 reportsJul 2024: 3 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 7 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 6 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Scratched Material173
  • Naturally Worn116
  • Break48
  • Material Twisted/Bent30
  • Material Deformation19
  • Illegible Information17
  • Peeled/Delaminated10
  • Device-Device Incompatibility7

Patient problems

  • No Clinical Signs, Symptoms or Conditions172
  • No Consequences Or Impact To Patient91
  • Insufficient Information5
  • Not Applicable5
  • No Code Available2
  • Bone Fracture(s)1
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 271 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 18, 2026Scratched Material; Illegible Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50824039 ↗
  • MalfunctionSep 18, 2026Scratched Material; Illegible Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50824000 ↗
  • MalfunctionSep 18, 2026Scratched Material; Illegible Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50823950 ↗
  • MalfunctionSep 18, 2026Scratched Material; Illegible Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50823852 ↗
  • MalfunctionSep 18, 2026Scratched Material; Illegible Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50823811 ↗
  • MalfunctionSep 18, 2026Scratched Material; Illegible Information

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50823780 ↗
  • MalfunctionAug 10, 2026Scratched Material; Illegible Information

    It was reported during inspection of sets it was determined the head trials were scratched. Possible compromise to sterility.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50191463 ↗
  • MalfunctionNov 26, 2025Break; Scratched Material; Break; Scratched Material

    IT WAS REPORTED THAT HEAD TRIAL IS SCRATCHED. PART OF IT CAME OFF ON THE BACK TABLE.

    Patient problems: Insufficient Information

    MAUDE report 23655654 ↗
  • MalfunctionMar 27, 2025Scratched Material; Illegible Information; Scratched Material; Illegible Information

    IT WAS REPORTED THAT THE HEAD TRIAL WAS SCRATCHED UP AND SURGICAL TEAM MEMBER WASN'T ABLE TO CONFIRM IF IT WAS THE CORRECT HEAD DIAMETER OR HEIGHT. THERE WAS NO DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21708177 ↗
  • MalfunctionJan 30, 2025Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

    IT WAS REPORTED THAT CCSD STAFF NOTICED THAT THE GREEN 32 +1 TRIAL HEAD HAS SCRATCHES IN IT IN THE CONSIGNMENT SET. THEY DID NOT WISH TO RESTERILISE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21276255 ↗
  • MalfunctionDec 2, 2024Break; Break

    IT WAS REPORTED THAT THE HEAD TRIAL 32 +1 IS BROKEN AND WORN. IT HAS 2 CHIPS IN IT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20823206 ↗
  • MalfunctionOct 31, 2024Scratched Material; Scratched Material

    IT WAS REPORTED THAT THE HEAD TRIAL WAS SCRATCHED. UNKNOWN SURGICAL DELAY.

    Patient problems: Insufficient Information

    MAUDE report 20579895 ↗
  • MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO ADVERSE CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20578478 ↗
  • MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material

    ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO ADVERSE CONSEQUENCES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20578437 ↗
  • MalfunctionOct 31, 2024Break; Material Deformation; Naturally Worn; Scratched Material; Break; Material Deformation; Naturally Worn; Scratched Material

    IT WAS REPORTED THAT THE HEAD TRIALS ARE WORN, SCRATCHED AND CHIPPED. IT DID NOT HAPPEN IN SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20578414 ↗
  • 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 20546382 ↗
  • MalfunctionOct 28, 2024Naturally Worn; Scratched Material; 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 20546289 ↗
  • 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 20546213 ↗
  • MalfunctionAug 20, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

    IT WAS REPORTED THAT THE 32 +1 HEAD TRIAL WAS SCRATCHED AND WAS NOT USED. THERE WAS NO SURGERY DELAY AND NO HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20002629 ↗
  • 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 19843458 ↗
  • 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 19843450 ↗
  • 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 ARTIC/EZE TR BALL GRVD PRESENTS SEVERAL SCRATCHES ALL OVER THE OUTER SURFACE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19644459 ↗
  • MalfunctionJun 27, 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 19629272 ↗
  • MalfunctionJun 26, 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 19618773 ↗
  • MalfunctionJun 19, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

    IT WAS REPORTED THAT HEAD BALL TRIAL HAS PLASTIC PEELING SHARDS PEELING OFF AND COULD CAUSE DAMAGE TO POLY. NOTHING LEFT IN PATIENT. NO DELAYS IN SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19569483 ↗

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Sources and updates

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