INHANCE 6105-10-040Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM GLENOID SIZER MEDIUM · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295538837), received between Aug 3, 2022 and Jul 8, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Crack” (6 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
- Crack6
- Break5
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information3
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Crack
IT WAS REPORTED THAT THE TIP OF THE STEM INSERTER WAS BROKEN, AND THE MEDIUM GLENOID SIZER WAS CRACKED DUE TO GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753519 ↗MalfunctionNov 26, 2025Crack; Crack
IT WAS REPORTED THAT WHEN EXTRACTING THE HUMERAL STEM PIN PUNCH, ONE OF THE PINS BROKE OFF. IT WAS RETRIEVED AND THE MEDIUM GLENOID SIZER CRACKED WHILE PUTTING IT ON THE SIZER HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658919 ↗MalfunctionMar 13, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT BOTH THE SMALL AND MEDIUM GLENOID SIZERS WERE CRACKED WHEN PUTTING INSTRUMENTS BACK TOGETHER AFTER CASE. THESE NEEDS TO BE REPLACED. ALL BROKEN PARTS WERE RETRIEVED AND NO SURGICAL DELAYS TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597709 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20075641 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20075631 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT THE MEASURING INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 20075614 ↗MalfunctionMar 18, 2024Crack; Crack
IT WAS REPORTED THAT THE SIZER HAS CRACKED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. 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 18922264 ↗MalfunctionFeb 5, 2024Crack; Crack
IT WAS REPORTED THAT MEDIUM HUMERAL SIZER CRACKED WHILE SIZING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640855 ↗MalfunctionOct 13, 2023Crack; Crack
IT WAS REPORTED THAT BOTH THE OFFSET ADAPTER AND MEDIUM GLENOID SIZE HAVE CRACKS IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929713 ↗MalfunctionMay 18, 2023Break; Break
IT WAS REPORTED THAT SIZER BROKE DURING SURGERY, WHILE BEING USED. ALL PIECES WERE RETRIEVED. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16952146 ↗MalfunctionAug 3, 2022No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE INHANCE GLENOID SIZERS GET LOST AT A RATE THAT FAR EXCEEDS NORMAL INSTRUMENTATION. THE SURGEON NEEDED THE SIZERS FOR THEIR CASES BUT ITS DIFFICULT WHEN THESE SIZERS ARE CONSTANTLY MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158103 ↗
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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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