MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT XS 33+3MM CONSTRAINED; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT XS 33+3MM CONSTRAINED
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/05/2024, it was reported by a sales representative via e-mail that an ar-9502f-33lcpc univers revers suture cup, ar-9503xs-03c humeral insert, and an ar-9501-05p univers revers¿ humeral stem failed in a case.This occurred during a revers total shoulder procedure on (b)(6) 2024 when the surgeon decided to change the poly size when trying to extract the implant.The rest of the construct became loose.They then had to exchange for a bigger stem, a new suture cup, and the correctly sized poly.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to user error due to misaligned insertion, incorrect size chosen and/or improper bone preparation.

• Brand Name: HUMERAL INSERT XS 33+3MM CONSTRAINED
• 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: 18943693
• Report Number: 1220246-2024-01575
• Device Sequence Number: 2894793
• Product Code: HSD
• UDI-Device Identifier: 00888867406865
• UDI-Public: 00888867406865
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/19/2025

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: HUMERAL INSERT XS 33+3MM CONSTRAINED
• Device Catalogue Number: AR-9503XS-03C
• Device Lot Number: 23.00357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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