MAUDE Adverse Event Report: ARTHREX, INC. REVERS CA HUMERAL HEAD, 50/19; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	REVERS CA HUMERAL HEAD, 50/19
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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.Two weeks after the surgery, 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 on (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
Additional information: d6a, 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 for the reported failure can be attributed to a patient-specific event.

• Brand Name: REVERS CA HUMERAL HEAD, 50/19
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 21559761
• Report Number: 1220246-2025-00869
• Device Sequence Number: 9261659
• Product Code: HSD
• UDI-Device Identifier: 00888867229532
• UDI-Public: 00888867229532
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: REVERS CA HUMERAL HEAD, 50/19
• Device Catalogue Number: AR-9550-19RCA
• Device Lot Number: 11010190
• 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: 06/09/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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