MAUDE Adverse Event Report: ARTHREX, INC. COMBINATION HUMERAL INSERT 33+3 / 36; SHOULDR PROSTH, REVERSE CONFIG

Model Number	COMBINATION HUMERAL INSERT 33+3 / 36
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
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 08-jan-2026, a sales representative reported via phone that an ar-9503-3336-3 univers revers¿ modular glenoid system would not seat properly when inserted into the shoulder cup.This occurred during a reverse total shoulder arthroplasty procedure.The device was removed and replaced with another ar-9503-3336-3, which allowed the procedure to be completed successfully.There were no procedural delay and no patient harm associated with this event.

• Brand Name: COMBINATION HUMERAL INSERT 33+3 / 36
• 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: 24160165
• Report Number: 1220246-2026-00287
• Device Sequence Number: 9028844
• Product Code: HSD
• UDI-Device Identifier: 00888867406476
• UDI-Public: (01)00888867406476(11)250101(17)291231(10)24.04675
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221232
• 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): 05/26/2026

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: COMBINATION HUMERAL INSERT 33+3 / 36
• Device Catalogue Number: AR-9503-3336-3
• Device Lot Number: 24.04675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/26/2026
• 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