MAUDE Adverse Event Report: Arthrex, Inc. ECLIPSE TRUNION 49MM, SLOTTED, TPS CaP4.; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ECLIPSE TRUNION 49MM, SLOTTED, TPS CaP4.
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury

• Brand Name: ECLIPSE TRUNION 49MM, SLOTTED, TPS CaP4.
• Common Device Name: TOT ANAT SHOULDR PROSTH, UNCEM
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50938383
• Report Number: 1220246-2026-04955
• Device Sequence Number: 13450868
• Product Code: QHQ
• UDI-Device Identifier: 00888867276178
• UDI-Public: 00888867276178
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: ECLIPSE TRUNION 49MM, SLOTTED, TPS CaP4.
• Device Catalogue Number: AR-9301-49CPC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• 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