MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/12/2025
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 who 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 metalosis 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 second revision which was performed on the (b)(6) 2025 is handled in (b)(4).The following devices were removed during the revision surgeries.Removed on saturday the (b)(6): suture cup 39 neutral - ar9502-39cpc, medium 39 plus 3 inlay - ar9503m-03, universal glenoid glenosphere 39 plus 4 - ar9504m-04.Removed on the (b)(6): 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 device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex was able to determine the most likely cause.The damage and wear of the implant likely contributed to the development of metallosis.Prolonged metal-on-metal contact may also be a contributing factor.The device failure is likely due to wear, potentially influenced by a combination of factors including poor initial implant positioning, prolonged use, an active lifestyle, and/or physically demanding work.Poor positioning may have led to wear, while patient-specific factors, such as extended use and physical activity, may have accelerated the degradation.Considering the implantation surgery that occurred in 2013, and the reported event took place on july 17, 2025, the observed wear is understandable after 12 years of an active lifestyle and physically demanding work.Directions for use - dfu-0189-eu-01-eo at revision 3 - univers revers shoulder prosthesis system j.Adverse effects 8.Loosening of the implant as a result of changed conditions in load transfer, respectively, 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 the above-listed risk conditions.In addition, a result of failure to achieve optimum positioning of the implant can cause dislocation, subluxation, or inadequate scope of movement.9.Dislocation, subluxation, or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant.10.Bone fractures as a result of one-sided overload or weakened bone substance.K.Warnings 21.An artificial joint is subject to wear and/or can loosen over a period of time.Wear and loosening may make it necessary to re-operate on an artificial joint.M.Precautions 3.Patient weight.An overweight patient may present additional risk.4.Extreme stress or strain resulting from work or sport related activity.5.Patients with an increased risk of fractures due to repeated strain or trauma, or medical conditions that increase the patient¿s risk for trauma, including falls.6.Osteoporosis or osteomalacia.The complaint allegation was confirmed based on the images attached to the relate (b)(4).

• Brand Name: HUMERAL INSERT M/39 +3 TO FIT IN 39 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: 22730828
• Report Number: 1220246-2025-03294
• Device Sequence Number: 8352840
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: 00888867061255
• 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 Implanted 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: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• 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): 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