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

Model Number	HUMERAL INSERT XS 33+3MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 2/10/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry suffered a loosening of the glenoid side implants.An x-ray on (b)(6) 2024, showed loss of fixation of the baseplate.The patient was revised on (b)(6) 2024.The event was indicated as possibly related to the univers revers implanted on (b)(6) 2023.No further information was provided.Additional information received on 3/7/2025: ar-9580-2410 univers revers modular glenoid system augmented baseplate, an ar-9582-25 modular post for augmented mgs baseplate, an ar-9563-16 univers revers modular glenoid system, peripheral screw, locking, three ar-9563-20 univers revers modular glenoid system, peripheral screw, locking, an ar-9564-2433-lat arthrex univers revers modular glenoid system glenosphere, and an ar-9503xs-03 univers revers modular glenoid system, humeral insert were explanted during the revision surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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.

• Brand Name: HUMERAL INSERT XS 33+3MM
• 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: 21700157
• Report Number: 1220246-2025-01143
• Device Sequence Number: 20998597
• Product Code: HSD
• UDI-Device Identifier: 00888867406469
• UDI-Public: (01)00888867406469(11)220901(17)270831(10)22.00680
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: HUMERAL INSERT XS 33+3MM
• Device Catalogue Number: AR-9503XS-03
• Device Lot Number: 22.00680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown