INHANCE 6105-10-030Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM GLENOID SIZER SMALL · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy INHANCE shoulder glenoid sizer is an instrument used to help size the shoulder socket during replacement surgery. The 26 reports mostly describe the sizer breaking or cracking, failing to attach or connect to its handle, or having scratched material; some reports mention parts being retrieved without surgical delays. There were no deaths or injuries, and 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295538820), received between Jun 1, 2023 and Mar 5, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Crack11
- Scratched Material3
- Device-Device Incompatibility2
- Contamination /Decontamination Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information11
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Crack
IT WAS REPORTED THAT SMALL GLENOID SIZER CRACKED, NEEDS TO BE REPLACED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24517815 ↗MalfunctionFeb 9, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT SURGICAL PROCEDURE, BOTH THE XS AND THE S GLENOID SIZERS WERE DAMAGED. THEY WERE NOT STAYING ATTACHED TO THE SIZER HANDLE. THERE WERE NO DELAYS OR ADVERSE EVENTS. ALL PARTS WERE RETRIEVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300664 ↗MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT HOSPITAL HAD LOST INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888647 ↗MalfunctionNov 14, 2025Crack; Crack
IT WAS REPORTED THAT THE SIZER HAD CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23556752 ↗MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SMALL GLENOID SIZER DISK WOULDN¿T THREAD OR CONNECT ONTO THE SIZER HANDLE. NOTHING BROKE OFF THE INSTRUMENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396517 ↗MalfunctionMar 21, 2025Crack; Crack
IT WAS REPORTED THAT SIZER WAS CRACKED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21665855 ↗MalfunctionMar 21, 2025Crack; Crack
IT WAS REPORTED THAT SIZER WAS CRACKED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21665827 ↗MalfunctionMar 14, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT BOTH THE SMALL AND MEDIUM GLENOID SIZERS WERE CRACKED WHEN PUTTING INSTRUMENTS BACK TOGETHER AFTER CASE. ALL BROKEN PARTS WERE RETRIEVED AND NO SURGICAL DELAYS TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604363 ↗MalfunctionJan 31, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: A. THERE WERE NO ADVERSE CONSEQUENCES. B. THE DISK BROKE INTO 2 PIECES. C. YES, BOTH PIECES WERE RETRIEVED. D. NO, SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21283509 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20075646 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20075644 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20075613 ↗MalfunctionAug 22, 2024Crack; Crack
IT WAS REPORTED THAT THE PLASTIC DISC HAS A CRACK NEED REPLACED. THE INSTRUMENT BROKE DURING SURGERY. THERE WAS LOOSENING. THERE WAS SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 20026652 ↗MalfunctionAug 12, 2024Break; Break
IT WAS REPORTED THAT THE GLENOID WAS FOUND CHIPPED IN SPD. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19961172 ↗MalfunctionJun 24, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19593296 ↗MalfunctionJun 24, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19593285 ↗MalfunctionMay 15, 2024Break; Break
IT WAS REPORTED THAT THE BOTH SIZERS BROKE. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19323341 ↗MalfunctionMay 15, 2024Break; Break
IT WAS REPORTED THAT THE BOTH SIZERS BROKE. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19323336 ↗MalfunctionApr 4, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE ITEMS ARE SCUFFED, AND STAFF WOULD NOT REPROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19040915 ↗MalfunctionMar 27, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIALS ARE SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18986033 ↗MalfunctionMar 18, 2024Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE GLENOID SIZER WAS DAMAGED , THERE WAS A CRACK IN THE PLASTIC PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923761 ↗MalfunctionFeb 29, 2024Crack; Crack
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE GLENOID SIZER CRACKED WHEN PLACING THE GLENOID PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18812784 ↗MalfunctionFeb 23, 2024Crack; Crack
IT WAS REPORTED THAT THE HUMERAL AND GLENOID SIZER BOTH CRACKED. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773817 ↗MalfunctionFeb 13, 2024Crack; Crack
ADDITIONAL INFORMATION RECEIVED. A. WAS/WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT, BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES. B. DID THE EVENT OCCUR, DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. C. WERE THERE PIECES BROKEN OFF FROM THE INSTRUMENT? IF YES, DID IT BREAK INTO 2 OR MORE PIECES? NO PIECES BROKEN OFF. D. WHAT PART OF THE INSTRUMENTS WERE BROKEN? HUMERAL HEAD TRIALS BROKE ON THE INSIDE, WHERE ADAPTER TRIAL FITS. VERSION INDICATOR PLASTIC PART CRACKED, SIZER AND GLENOID TRIALS CRACKED, INSERTER TIP THREADS WORN E. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18693916 ↗MalfunctionJan 29, 2024Crack; Crack
IT WAS REPORTED THAT UPON REMOVAL OF THE SMALL GLENOID SIZER DISC, IT WAS DISCOVERED THAT THE SIZER DISC WAS CRACKED. IT DID NOT FRAGMENT AND NO PIECES WERE LEFT BEHIND.
Patient problems: Insufficient Information
MAUDE report 18595459 ↗
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- 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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