INHANCE 5200-02-036Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM STANDARD STEM MEDIUM Ø36mm X 115mm · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295547105), received between Jun 11, 2024 and Sep 15, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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 Problem6
- Use of Device Problem1
Patient problems
- Unspecified Infection4
- Bone Fracture(s)2
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revision due to infection/fracture from fall.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Right.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 50772444 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A CLINICAL ADVERSE EVENT RECEIVED FOR PROXIMAL HUMERUS FRACTURE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: 6 MAY 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NONE/OBSERVATION: YES. DEPUY SYNTHES PRODUCTS USED: COMPONENT TYPE: SCREW. CATALOG NUMBER: 550310030. LOT NUMBER: 240825. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020. LOT NUMBER: 233599. COMPONENT TYPE: SCREW. UNIQUE DEVICE ID: (B)(4). COMPONENT TYPE: SCREW. CATALOG NUMBER: 550310015. LOT NUMBER: 234384. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550035600. LOT NUMBER: 238056. COMPONENT TYPE: SCREW. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520002036. LOT NUMBER: 62141. COMPONENT TYPE: STEM. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536108. LOT NUMBER: 344527. COMPONENT TYPE: GLENOSPHERE. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360. LOT NUMBER: 664810. COMPONENT TYPE: SHELL. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240. LOT NUMBER: 665331. COMPONENT TYPE: BASEPLATE. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550036000. LOT NUMBER: MI192
Patient problems: Bone Fracture(s)
MAUDE report 25447807 ↗InjuryDec 5, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO WASHOUT FOR INFECTION. THE DOCTOR DECIDED TO CHANGE THE STEM TO PUT IT IN A BETTER POSITION WHILE HE WAS IN THIS PROCEDURE. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 23730416 ↗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 22594496 ↗InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PROBABLE INFECTION. ORIGINAL IMPLANT DATE WAS (B)(6) 2023.
Patient problems: Unspecified Infection
MAUDE report 20501379 ↗InjuryJun 11, 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 UNSTABLE AND DISLOCATED SHOULDER. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19513058 ↗
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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