MAUDE Adverse Event Report: ARTHREX, INC. 36+6 / 39 COMBINATION HUMERAL INSERT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	36+6 / 39 COMBINATION HUMERAL INSERT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 (b)(6) 2024, it was reported by a sales representative via email that an ar-9503-3639-6 univers revers modular glenoid system, combo humeral insert, 36 +6 / 39, had the polly not seating correctly in a cup.Another implant was used to complete the case.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 01/02/2024: this was discovered during a rtsa procedure on (b)(6) 2024.Another humeral insert was used to complete the case.There was no case delay.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The reported failure is most likely attributable to user error in the placement of the implant onto the cup.The complaint allegation was not confirmed.The device was not received, and no evidence of the failure was received.

• Brand Name: 36+6 / 39 COMBINATION HUMERAL INSERT
• 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: 21183073
• Report Number: 1220246-2025-00003
• Device Sequence Number: 8722103
• Product Code: PHX
• UDI-Device Identifier: 00888867308879
• UDI-Public: (01)00888867308879(11)210901(17)260831(10)21.01088
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191960
• 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): 09/10/2025

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 Expiration Date: 08/31/2026
• Device Model Number: 36+6 / 39 COMBINATION HUMERAL INSERT
• Device Catalogue Number: AR-9503-3639-6
• Device Lot Number: 21.01088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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