INHANCE 5500-30-600Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM CENTRAL SCREW Ø6.0 X 30mm · 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 10603295548836), received between Jun 20, 2024 and Jun 9, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Fracture” (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 Problem7
- Fracture1
Patient problems
- Unspecified Infection6
- Insufficient Information1
- Pain1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Fracture
IT WAS REPORTED THAT THE SHOULDER WAS REVISED BECAUSE OF BROKEN PERIPHERAL AND CENTER SCREW. IMPLANTS WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 25446590 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 24568122 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 8 JAN 2026. DATE OF IMPLANT: ON (B)(6) 2025. DATE OF REVISION: ON (B)(6). 2026 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (CUP). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240, LOT NUMBER: 664514, COMPONENT TYPE: BASEPLATE, DESCRIPTION: MODULAR UNITI PLATFORM BASEPLATE S 24, CATALOG NUMBER: 550030600, LOT NUMBER: 227541, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE CENTRAL SCREW 6.0X30, CATALOG NUMBER: 550300500, LOT NUMBER: 235418, COMPONENT TYPE: SCREW, DESCRIPTION: INHANCE 4PK LOCKING SCRW 2025 SLFDRILL, CATALOG NUMBER: 550536004, LOT NUMBER: 350285, COMPONENT TYPE: GLENOID, DESCRIPTION: INHANCE GLENOSPHERE 36+4, CATALOG NUMBER: 520001040, LOT NUMBER: 664294, COMPONENT TYPE: STEM, DESCRIPTION: INHANCE SHORT STEM L 40, CATALOG NUMBER: 550000400, LOT NUMBER: 664524, COMPONENT TYPE: SHELL, DESCRIPTION: INHANCE REVERSE HUMERAL SHELL L 40+0, CATALOG NUMBER: 550036104, LOT NUMBER: MI125080, COMPONENT TYPE: LINER, DESCRIPTION: INHANC
Patient problems: Unspecified Infection
MAUDE report 24232981 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 8 JAN 2026, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2026, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (CUP) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550011240 LOT NUMBER: 664514 COMPONENT TYPE: BASEPLATE DESCRIPTION: MODULAR UNITI PLATFORM BASEPLATE S 24. CATALOG NUMBER: 550030600 LOT NUMBER: 227541 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE CENTRAL SCREW 6.0X30. CATALOG NUMBER: 550300500 LOT NUMBER: 235418 COMPONENT TYPE: SCREW DESCRIPTION: INHANCE 4PK LOCKING SCRW 2025 SLFDRILL. CATALOG NUMBER: 550536004 LOT NUMBER: 350285 COMPONENT TYPE: GLENOID DESCRIPTION: INHANCE GLENOSPHERE 36+4. CATALOG NUMBER: 520001040 LOT NUMBER: 664294 COMPONENT TYPE: STEM DESCRIPTION: INHANCE SHORT STEM L 40. CATALOG NUMBER: 550000400 LOT NUMBER: 664524 COMPONENT TYPE: SHELL DESCRIPTION: INHANCE REVERSE HUMERAL SHELL L 40+0. CATALOG NUMBER: 550036104 LOT NUMBER: MI125080 COMPONENT TYPE: LINER DESCRIPTION: INHANCE REVERSE LINER 36+4 R.
Patient problems: Unspecified Infection
MAUDE report 24232947 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO SHOULDER WAS INFECTED, SURGEON PULLED COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 24039236 ↗InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 22594436 ↗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 22522972 ↗InjuryJun 20, 2024Adverse 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Pain
MAUDE report 19574827 ↗
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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