INHANCE 5100-24-022Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID SMALL Ø24mm CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY · Class 2 · Implant
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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295549161), received between Nov 15, 2024 and Feb 5, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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
- Loss of or Failure to Bond2
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Bone Fracture(s)1
- Foreign Body Reaction1
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2026Loss of or Failure to Bond; Fracture
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE DARK BUILD UP COVERING HUMERUS WAS METALLOSIS.
Patient problems: Foreign Body Reaction; Insufficient Information
MAUDE report 24272017 ↗InjuryJan 6, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENTS GLENOID POPPED OUT. SURGEON CONVERTED SHOULDER INTO REVERSE SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Inadequate Osseointegration
MAUDE report 23979434 ↗InjuryApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT DISLOCATED POSTERIORLY AND NEEDED A REVISION FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 21780248 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ONE WEEK AFTER SURGERY, THE PATIENT PUSHED OFF OF OPERATIVE ARM AND FX GLENOID RESULTING IN THE BASEPLATE COMING LOOSE OF THE GLENOID. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Bone Fracture(s)
MAUDE report 20693713 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- BIO-MODULAR SHOULDER SYSTEM 113865Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114648Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113863Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- BIO-MODULAR SHOULDER SYSTEM 113867Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 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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