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

Model Number	MODULAR POST, 30MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/24/2025, a sales representative reported via email that an ar-9580-2420 24mm baseplate, 20° full augment, and an ar-9582-30 modular post became loose after 1.5 years post-implantation.There were no signs of infection, and the surgeon confirmed no history of trauma or fall.The issue was identified on (b)(6) 2025.Additional information has been requested on 07/31/2025.
Additional Manufacturer Narrative
Additional information: 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 of the reported failure can be attributed to a patient-specific event.As stated per the univers revers¿ augmented modular glenoid system surgical technique lt1-000169-en-us: the patient¿s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.Conditions that tend to limit the patient¿s ability or willingness to restrict activities or follow directions during the healing period.The use of this device may not be suitable for patients with insufficient or immature bone.The physician should carefully assess bone quality before performing orthopedic surgery.The use of this medical device and the placement of hardware or implants must not bridge, disturb or disrupt the growth plate.

• 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: 22773341
• Report Number: 1220246-2025-03410
• Device Sequence Number: 13083562
• Product Code: PHX
• UDI-Device Identifier: 00888867341852
• UDI-Public: (01)00888867341852(11)231201(17)281130(10)1408142249
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODULAR POST, 30MM
• Device Catalogue Number: AR-9582-30
• Device Lot Number: 1408142249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown