MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	24MM BASEPLATE, MODULAR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/12/2025, it was reported by a sales representative via (b)(4) that an ar-9560-24 arthrex univers revers modular glenoid system baseplate would not engage with an ar-9561-25s univers revers modular glenoid system, central screw.The surgeon ensured having past the minimum line and everything appeared as it should, but the implants did not mate properly.The case was completed with a new implant.This was discovered during an rtsa procedure on (b)(6) 2025.Additional information requested on 3/18/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
This occurred while the baseplate was in the patient already screwed in and then it was realized that the baseplate and central screw separated.Nothing broke inside the patient.The case was completed using an ar-9560-24 arthrex univers revers baseplate and an ar-9561-25s arthrex univers revers central screw.The case was delayed less than five minutes under normal anesthesia.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the edges around the tip's hex of the arthrex® univers revers¿ modular glenoid system modulas baseplate 24 mm were damaged.Functional testing was performed, but due to the damage to the device, it did not lock properly.Per surgical technique of the univers revers¿ modular glenoid system.# 7 there is a hex tip that must be aligned between the components in order for the taper to engage (see illustration).Rotate the components until the hex features align, resulting in a tactile coupling.Place the joined components within the taper assembly stand so that the central post/screw is facing up.The most likely cause for the reported failure can be attributed to user error due to misalignment of the hex tip into the taper to engage.

• Brand Name: 24MM BASEPLATE, MODULAR
• 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: 21751157
• Report Number: 1220246-2025-01165
• Device Sequence Number: 18164509
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: (01)00888867296411(11)241118(17)291031(10)15349325
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• 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): 07/17/2025

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: 24MM BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 15349325
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown