MAUDE Adverse Event Report: ARTHREX, INC. MODULAR POST, 30MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	MODULAR POST, 30MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/24/2025
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 07/25/2025, a sales representative reported via email that the ar-9580-2420-2s univers revers modular glenoid system augmented baseplate (24 mm) had failed, necessitating a revision procedure.The issue originated during a reverse shoulder arthroplasty performed on 07/24/2025.To address the failure, the surgical team successfully removed the ar-9580-2420-2s baseplate (24 mm), ar-9582-30 modular post for augmented mgs baseplate 30 mm, ar-9563-24 peripheral locking screw, and ar-9563-36 peripheral locking screw.They proceeded with the implantation of a non-arthrex small screw baseplate, which was supplemented by bone grafting.A new arthrex cup and polyethylene liner were also placed.The revision surgery was completed without further complications.Additional information has been requested on 07/31/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided x-ray images noted an ar-9582-30 univers revers¿ augmented modular glenoid system.Refer to attachments.Based on the information provided, arthrex was not able to confirm the alleged failure.The most likely cause of the reported failure can be attributed to a patient-specific event.Ref: lt1-000169-en-us univers revers¿ augmented modular glenoid system surgical technique.

• Brand Name: MODULAR POST, 30MM
• 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: 22792985
• Report Number: 1220246-2025-03457
• Device Sequence Number: 8634286
• Product Code: PHX
• UDI-Device Identifier: 00888867341852
• UDI-Public: (01)00888867341852(11)241001(17)290930(10)1657502351
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: MODULAR POST, 30MM
• Device Catalogue Number: AR-9582-30
• Device Lot Number: 1657502351
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown