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 Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 2/25/2025, it was reported by a sales representative via email that ar-9501-04-135p univers revers stem would not engage with an ar-9504-06 univers revers spacer.The stem was implanted over a month ago and it would not engage.This was discovered during a revision surgery.No further information was reported.Additional information received on 3/3/2025: the patient underwent an initial rtsa procedure on (b)(6) 2024.On (b)(6) 2025, the patient underwent a revision surgery in which two ar-9504-06 univers revers spacers would not engage with the stem.Additional information received on 3/11/2025: the patient underwent revision surgery due to a shoulder dislocation.During the revision, an ar-9503xs-06 univers revers modular glenoid system humeral insert was explanted and an ar-9503-3336-6c univers revers modular glenoid system, constrained combo humeral insert was implanted.Additional information received on 3/24/2025: ar-9564-2433-lat arthrex univers revers glenosphere were explanted as well.Ar-9503-3336-3 univers revers combo humeral insert was attempted to be used with the spacer but it would not fit, so the surgeon turned to an ar-9503-3336-6c univers revers modular glenoid system, constrained combo humeral insert.It was also reported that the screw from the initial ar-9504-06 univers revers spacer was not working and an ar-9502rsc univers revers replacement cup screw had to be used.
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 a patient-specific event likely due to the patient's anatomy.

• 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: 21884134
• Report Number: 1220246-2025-01648
• Device Sequence Number: 3552939
• Product Code: HSD
• UDI-Device Identifier: 00888867406476
• UDI-Public: (01)00888867406476(11)240501(17)290430(10)23.05479
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/09/2025

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: COMBINATION HUMERAL INSERT 33+3 / 36
• Device Catalogue Number: AR-9503-3336-3
• Device Lot Number: 23.05479
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown