INHANCE 5505-40-104Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM GLENOSPHERE ECCENTRIC Ø40+4mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295547167), received between Oct 18, 2024 and May 1, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated3
Patient problems
- Joint Dislocation3
- Unspecified Infection3
- Joint Laxity2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT COMES IN TODAY HAVING PROBLEMS WITH CHRONIC DISLOCATIONS. THE PATIENT LIFTED A HEAVY BOX 4 WEEKS POST OP AND DISLOCATED CAUSING MORE PROBLEMS. THE DOCTOR DECIDED IT BEST TO REMOVE HIS GLENOSPHERE AND POLY TO REBALANCE THE SHOULDER. WHILE DOING THIS THE PROXIMAL HUMERUS FRACTURED SO HE REMOVED THE STEM AND SHELL AS WELL. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 25056044 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DOCTOR PERFORMED IRRIGATION AND DEBRIDEMENT WITH MODULAR COMPONENT EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 24681734 ↗InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND NEEDED LATERALIZED GLENOSPHERE, THICKER POLY. AFFECTED SIDE: UNKNOWN SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 22541721 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE TAKEN OUT. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 22522963 ↗InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ENHANCE REVERSE TOTAL SHOULDER WAS UNSTABLE WITH TOO MUCH LAXITY TO FUNCTION PROPERLY. HUMERAL HEAD AND HUMERAL LINER WERE REMOVED AND UPSIZED TO CREATE MORE STABILITY IN THE GLENOHUMERAL JOINT. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 22507750 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THE GLENOSPHERE, SHELL, AND POLY WERE REMOVED AND REPLACED WITH DIFFERENT SIZES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Laxity
MAUDE report 22332115 ↗InjuryApr 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT WAS REVISED; CAUSED BY DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 21921755 ↗InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY AT A HOSPITAL ON (B)(4) 2023. PATIENT SHOULDER WAS INFECTED, SO DOCTOR FELT THEY WOULD BENEFIT FROM A WASHOUT OF THEIR SHOULDER AND AN EXCHANGE OF THE HUMERAL SHELL, POLY, AND GLENOSPHERE. THOSE IMPLANTS WERE REMOVED, THE SHOULDER WAS THOROUGHLY WASHED OUT, AND NEW IMPLANTS WERE INSERTED. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WERE NO ADVERSE EVENTS OR DELAYS THAT TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 20480209 ↗
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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