MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM, SIZE 9, CAP COATED; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS REVERS STEM, SIZE 9, CAP COATED
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/17/2025
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
It was reported that after a patient was treated in 2013 with an univers revers with a 36 suture cup and a universal glenoid (39 glenosphere).The patient had a gut surgery recently and started feeling unwell and having shoulder pain.The patient visited the surgeon whom then discovered that there was an infection in the right shoulder and saw component loosening and wear in the ct scan.At first the surgeon removed the glenosphere and suture cup which were already loose on the (b)(6) 2025 and took samples to determine the source of the infection.The surgeon then reported on the (b)(6) that everything had to be removed out due to the pathogen being a more serious.Upon removal, the surgeon saw a severe metallosis and tissue changes around the implant and the implant itself was completely worn.It was further reported that there was no report of a patient accident such as a fall or other injury that may have caused this.***update dw 21-jul-2025 further clarification was provided that there were 2 revisions, the first one was performed on the (b)(6) and a second one on (b)(6).The first revision which was performed on the (b)(6) 2025 is handled in case-(b)(4).The following devices were removed during the revision surgeries.Removed on saturday the 12th: suture cup 39 neutral - ar9502-39cpc medium 39 plus 3 inlay - ar9503m-03 universal glenoid glenosphere 39 plus 4 - ar9504m-04.Removed on the 17th: size 9 stem ar- 9501-09cpc 3 screws (sizes not known) ar-9120-02pc.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.A most likely cause can be patient-specific, related to infection and subsequent revision surgeries performed to address infection and loosening of components.

• Brand Name: UNIVERS REVERS STEM, SIZE 9, CAP COATED
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 22728824
• Report Number: 1220246-2025-03276
• Device Sequence Number: 12834228
• Product Code: PHX
• UDI-Device Identifier: 00888867061033
• UDI-Public: 00888867061033
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: UNIVERS REVERS STEM, SIZE 9, CAP COATED
• Device Catalogue Number: AR-9501-09CPC
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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