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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/29/2025, a sales representative reported via email that an ar-9503xs-03c univers revers modular glenoid system poly, located on the humeral side of a reverse shoulder implant, exhibited wear and cracking during use.A fragment broke off and fell inside the patient and was retrieved.The case report noted exposure to bodily fluid and infection.The case was completed, and no additional details were provided.This was discovered during a reverse total shoulder arthroplasty procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.The complaint device was not received for evaluation.Visual evaluation of the customer provided photo noted the device was worn and cracked.Refer to attachments.Based on the information provided which may include pictures, and the event description, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• 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: 22095559
• Report Number: 1220246-2025-02240
• Device Sequence Number: 15468798
• Product Code: HSD
• UDI-Device Identifier: 00888867406865
• UDI-Public: (01)00888867406865(11)220501(17)270430(10)22.00685
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/29/2025

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: 22.00685
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown