MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX STEM, SIZE 11; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS APEX STEM, SIZE 11
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an inverse shoulder prosthesis surgery on (b)(6) 2026 the patient has developed an infection.On (b)(6) 2026 all implants were removed and the affected areas were cleansed and treated.A new prosthesis will be implanted in 6-8 weeks.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UNIVERS REVERS APEX STEM, SIZE 11
• 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: 24895178
• Report Number: 1220246-2026-02248
• Device Sequence Number: 13020875
• Product Code: PHX
• UDI-Device Identifier: 00888867250529
• UDI-Public: (01)00888867250529(11)241201(17)291130(10)24.03266
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K170414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: UNIVERS REVERS APEX STEM, SIZE 11
• Device Catalogue Number: AR-9501-11S
• Device Lot Number: 24.03266
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown