INHANCE 5100-29-022Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID LARGE Ø29mm 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
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295549147), received between Jan 28, 2025 and Aug 17, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).
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
- Adverse Event Without Identified Device or Use Problem4
- Device Damaged Prior to Receipt by User1
Patient problems
- Unspecified Tissue Injury3
- Joint Laxity2
- Bone Notching1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that Humeral fracture didn't heal, glenoid was loose. Replaced Glenoid with convertible baseplate and poly. New humeral head with change in eccentricity.Affected Side: Unknown Shoulder.
Patient problems: Bone Notching; Joint Laxity
MAUDE report 50275751 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER THE INITIAL SURGERY THE PATIENT UNFORTUNATELY SUFFERED FROM ROTATOR CUFF FAILURE AND THEIR SHOULDER NEEDED TO BE CONVERTED. THE HUMERAL HEAD, ANATOMIC ADAPTER, AND HYBRID GLENOID WERE REMOVED. GLENOID WAS THEN PREPPED FOR A REVERSE BASEPLATE AND GLENOSPHERE. HUMERAL SIDE WAS THEN CONVERTED TO A HUMERAL SHELL AND POLY. STABILITY OF THE SHOULDER WAS CONFIRMED WITH TRIAL COMPONENTS BEFORE DEFINITIVE IMPLANTS WERE OPENED AND IMPLANTED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. AFFECTED SIDE: RIGHT.
Patient problems: Unspecified Tissue Injury
MAUDE report 24999919 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO LOST ROTATOR CUFF FUNCTION. ENHANCE ANATOMIC WAS CONVERTED TO REVERSE. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Tissue Injury
MAUDE report 24189606 ↗MalfunctionOct 15, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT WHEN THE IMPLANT WAS OPENED, IT COULD NOT BE IMPLANTED BECAUSE THE NO TOUCH TECHNOLOGY INSERTER WAS NOT GRIPPING IMPLANT PROPERLY. THE IMPLANT ITSELF WAS NOT DAMAGED; IT WAS SOLELY THE INSERTER PLASTIC WAS LOOSE. A NEW LARGE GLENOID WAS OPENED AND PROBLEM RESOLVED INSTANTLY. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304241 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD THEIR SHOULDER DONE ON (B)(6) 2024. UNFORTUNATELY, THE LESSER TUBEROSITY REPAIR FROM THE ANATOMIC SURGERY FAILED. DOCTOR FELT THE PATIENT WOULD BENEFIT FROM CONVERTING THEIR SHOULDER TO A REVERSE. THE GLENOID IMPLANT WAS REMOVED AND PREPPED FOR A REVERSE BASEPLATE AND GLENOSPHERE. A SHELL AND POLY WAS TRAILED ON THE EXISTING STEM AND THE SHOULDER WAS REDUCED. REAL IMPLANTS WERE OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Laxity; Unspecified Tissue Injury
MAUDE report 21251501 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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