MAUDE Adverse Event Report: ARTHREX, INC. 36+3 / 39 COMBINATION HUMERAL INSERT; SHOULDR PROSTH, REVERSE CONFIG

Model Number	36+3 / 39 COMBINATION HUMERAL INSERT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12/18/2024, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry, five months postoperative, presented with fullness in the anterior of the deltopectoral incision, which has to be fluctuance.The incision was drained, and a culture was sent to the lab, which indicated an infection.The physician decided to place a picc line for iv antibiotics.The patient also underwent an explant procedure and had an antibiotic cement spacer implanted on (b)(6) 2024.The patient was originally implanted on (b)(6) 2024.This event was indicated as unrelated to the univers revers apex implant system.Additional information received on 1/3/2024: during the revision surgery, an ar-9503-3639-3 humeral insert, an ar-9563-16 peripheral screw, an ar-9563-24 peripheral screw, an ar-9563-32 peripheral screw, an ar-9563-44 peripheral screw, an ar-9564-2439-lat glenosphere, an ar-9580-2420-2s baseplate, and ar-9582-25 modular post were explanted.The revision surgery was completed using products from another manufacturer.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6a, d6b, 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.

• Brand Name: 36+3 / 39 COMBINATION HUMERAL INSERT
• 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: 21160445
• Report Number: 1220246-2025-09477
• Device Sequence Number: 18035800
• Product Code: PHX
• UDI-Device Identifier: 00888867308862
• UDI-Public: (01)00888867308862(11)230801(17)280731(10)23.00510
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 36+3 / 39 COMBINATION HUMERAL INSERT
• Device Catalogue Number: AR-9503-3639-3
• Device Lot Number: 23.00510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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