MAUDE Adverse Event Report: ARTHREX, INC. COMBINATION HUMERAL INSERT 33+3 / 36; SHOULDR PROSTH, REVERSE CONFIG

Model Number	COMBINATION HUMERAL INSERT 33+3 / 36
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/11/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry suffered a bone fracture in the targeted shoulder.About seven months post operation, the patient made a quick turn around and ended up fracturing the glenoid cavity of right scapula.This was confirmed via a ct scan on (b)(6)2024.The patients pain began to improve as of (b)(6)2024.The patient reported decreased range of motion on (b)(6)2024 and sharp pain on (b)(6)2025.The patient underwent a revision surgery on (b)(6)2025.This event was indicated as unrelated to the univers revers system implanted on (b)(6)2024.Additional information received on 2/21/2025: during the revision surgery on (b)(6)2024, an ar-9550-19rca univers revers ca humeral head, an ar-9501-04-135r univers revers stem, an ar-9503-3336-3 univers revers modular glenoid system humeral insert, an ar-9563-16 univers revers modular glenoid system peripheral screw, an ar-9563-24 univers revers modular glenoid system, peripheral screw, locking, an ar-9563-28 univers revers modular glenoid system, peripheral screw, locking, an ar-9564-2436 arthrex univers revers modular glenoid system glenosphere, an ar-9580-2420-2s univers revers modular glenoid system augmented base plate, and an ar-9582-20 modular post for augmented mgs baseplate were explanted.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6b, g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is a patient-specific event.

• Brand Name: COMBINATION HUMERAL INSERT 33+3 / 36
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21559785
• Report Number: 1220246-2025-00868
• Device Sequence Number: 18457059
• Product Code: HSD
• UDI-Device Identifier: 00888867406476
• UDI-Public: 00888867406476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: COMBINATION HUMERAL INSERT 33+3 / 36
• Device Catalogue Number: AR-9503-3336-3
• Device Lot Number: 23.01220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown