MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 1/8/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry suffered a subluxation, which resulted in a revision of the components on (b)(6) 2023.The event was indicated as unrelated to the univers revers apex system implanted on (b)(6) 2023.No further information was provided.Additional information received on 2/25/2025 via clindex notification: on (b)(6) 2023, the patient reported instability, pain, and weakness.On (b)(6) 2024, the patient returned and reported difficulty with raising the arm along with continued instability, pain, and weakness.On (b)(6) 2024, the patient underwent revision surgery.Additional information was received on 3/7/2025.During the revision surgery on (b)(6) 2024, an ar-9564-2436-lat arthrex univers revers glenosphere, an ar-9580-2420-2 univers revers augmented baseplate, an ar-9501-10s univers revers apex humeral stem, and an ar-9503s-03 arthrex univers revers humeral insert were explanted.The case was completed using a new glenosphere, a humeral insert, a spacer, and a baseplate.
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.Complaint allegation is confirmed by the attached x-rays pictures, which shows a subluxation.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 of the reported failure can be attributed to a patient-specific event, resulting from a subluxation, which subsequently led to adverse outcomes necessitating revision surgery.

• Brand Name: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• 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: 21664997
• Report Number: 1220246-2025-01114
• Device Sequence Number: 12701642
• Product Code: PHX
• UDI-Device Identifier: 00888867061293
• UDI-Public: (01)00888867061293(11)230301(17)280229(10)22.04113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-03
• Device Lot Number: 22.04113
• 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: 09/04/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown