MAUDE Adverse Event Report: ARTHREX, INC. REVERS GLENOID POROUS COAT- BASEPLATE, M; SHOULDR PROSTH, REVERSE CONFIG

Model Number	REVERS GLENOID POROUS COAT- BASEPLATE, M
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-9120-02pc observed during a revision surgery.Based on the available information ¿ including the event description and field input ¿ arthrex has determined that the most likely cause is patient-specific, related to infection and subsequent revision surgeries performed to address infection and loosening of components.Per dfu-0170-eo revision 1, section d (adverse effects), items 8¿13: loosening of the implant may occur as a result of changes in load transfer, fatigue wear, or breakage of the cement bed, and/or tissue reaction to the implant.Loosening is frequently a consequence of one or several of these risk conditions.Failure to achieve optimum positioning of the implant can cause dislocation, subluxation, or inadequate scope of movement.Additional risks include bone fractures due to overload or weakened bone substance, cardiovascular complications (e.G., venous thrombosis, pulmonary embolism), wound hematoma, delayed wound healing, and tissue reactions caused by allergic responses or wear particle accumulation.

• Brand Name: REVERS GLENOID POROUS COAT- BASEPLATE, M
• 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: 22728827
• Report Number: 1220246-2025-03280
• Device Sequence Number: 15525905
• Product Code: MBF
• UDI-Device Identifier: 00888867286566
• UDI-Public: 00888867286566
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182039
• 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): 11/20/2025

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: REVERS GLENOID POROUS COAT- BASEPLATE, M
• Device Catalogue Number: AR-9120-02PC
• 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: 11/14/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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