INHANCE 6105-20-040Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM ANATOMIC GLENOID TRIAL MEDIUM · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295538882), received between Jan 11, 2023 and May 1, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL WAS CHIPPED. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942347 ↗MalfunctionMay 1, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL IS CHIPPED. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942177 ↗MalfunctionNov 14, 2023Break; Break
IT WAS REPORTED THAT TRIALS BROKE WHILE TRIALING. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136892 ↗MalfunctionJan 11, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT SEVERAL TRIAL BROKEN INSTRUMENTS. WEAR AND TEAR OF PRODUCT. TRIAL GLENOID CHIPPED WHILE IMPACTING. TRIAL HEADS SNAPPED WHILE ENGAGING/DISENGAGING OFFSET TAPER ADAPTER. HEAD IMPACTOR BROKE WHILE IMPLANTING FINAL IMPLANTS. THERE WAS 10 MINUTES SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16137025 ↗
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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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