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

Model Number	MODULAR POST, 30MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
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 11/19/2025, a sales representative reported via email that during the insertion of an ar-9582-30 modular post and an ar-9580-2420-2s baseplate, the two components did not engage properly, resulting in separation.A second set of components, another post and baseplate, was opened to successfully complete the procedure.This was discovered during a reverse total shoulder on (b)(6) 2025.Additional information was received on 11/25/2025: during the procedure, the ar-9582-30 modular post and the ar-9580-2420-2s baseplate disengaged inside the patient after being assembled on the back table.No components broke, and all pieces were retrieved.No other arthrex products were affected.The case was completed using ar-9580-2420-2s modular glenoid system augmented base plate 24 mm+2 (lot 1306512225) and ar-9582-30 modular post for augmented mgs baseplate 30 mm (lot 1749132422).Surgery was delayed by approximately 5¿10 minutes; the additional use of anesthesia is unknown.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as incomplete seating or component misalignment.

• 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: 23757405
• Report Number: 1220246-2025-05508
• Device Sequence Number: 15978834
• Product Code: PHX
• UDI-Device Identifier: 00888867341852
• UDI-Public: (01)00888867341852(11)250101(17)291231(10)1726052416
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/24/2026

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: 1726052416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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
• Patient Sex: Unknown