MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ECLIPSE CAGE SCREW M, 35MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pe inlay ar-9121-02 of the universal glenoid got worn off, resulting in metal-on-metal contact between eclipse humeral head and the baseplate of the universal glenoid.This resulted in metallose and related problems requiring a revision surgery with a conversion to a reverse prostehsis.During the revision surgery the eclipse humeral components and the remaining parts of the inlay were removed and proper seating of the universal glenoid baseplate was confirmed.Then a glenosphere was inserted onto the baseplate and the univers revers humeral components were implanted.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• Common Device Name: TOT ANAT SHOULDR PROSTH, UNCEM
• 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: 23927368
• Report Number: 1220246-2025-05893
• Device Sequence Number: 13032217
• Product Code: QHQ
• UDI-Device Identifier: 00888867059931
• UDI-Public: 00888867059931
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• 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