MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL SPACER 33+6MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL SPACER 33+6MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
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 12/4/2025.On 2/24/2025, 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.
Event or Problem Description
Additional information received on 3/24/025: 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: b5, h3, h6.
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: HUMERAL SPACER 33+6MM
• 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: 21641445
• Report Number: 1220246-2025-01012
• Device Sequence Number: 7574580
• Product Code: HSD
• UDI-Device Identifier: 00888867406902
• UDI-Public: (01)00888867406902(11)230601(17)280531(10)23.01069
• 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,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: HUMERAL SPACER 33+6MM
• Device Catalogue Number: AR-9504-06
• Device Lot Number: 23.01069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided; 10/02/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/21/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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