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

Model Number	24MM BASEPLATE, MONOBLOCK POST
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/15/2025
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 (b)(6) 2025, a patient reported via phone that they underwent a total right shoulder reverse arthroplasty on (b)(6) 2025 with implantation of an arthrex device.The patient has been attending physical therapy and expressed concern about not achieving the desired range of motion but reported no pain or inflammation at the surgical site.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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, due to postoperative care management rather than device performance or malfunction of the device.
Additional Manufacturer Narrative
Additional information: b5, d1, d2b, d4, g4, h3, h6.
Event or Problem Description
Additional information was received on 16-feb-2026: the arthrex device implanted during the patient¿s right shoulder reverse arthroplasty on (b)(6) 2025 included an ar-9560-24p arthrex univers reverse modular glenoid system monoblock post baseplate (24 mm).No further information was provided.

• Brand Name: 24MM BASEPLATE, MONOBLOCK POST
• 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: 24038238
• Report Number: 1220246-2026-00159
• Device Sequence Number: 9075000
• Product Code: PHX
• UDI-Device Identifier: 00888867296459
• UDI-Public: 00888867296459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: 24MM BASEPLATE, MONOBLOCK POST
• Device Catalogue Number: AR-9560-24P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: Not provided; 04/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/02/2026; 04/21/2026
• 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