MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2023
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
On 2/17/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry suffered a ruptured subscapularis due to a traumatic fall.The patient underwent revision surgery of the anatomic shoulder replacement to a reverse shoulder arthroplasty on (b)(6) 2023.The event was indicated as unrelated to the eclipse system implanted on (b)(6) 2023.Additional information received on 2/27/2025: on (b)(6) 2023, the patient underwent revision surgery to have an ar-9301-45cpc arthrex eclipse trunion, an ar-9106-02 arthrex univers vaultlock glenoid, an ar-9301-03 arthrex eclipse cage screw large, and an ar-9345-17 arthrex eclipse humeral head removed.After the surgery, the patient is doing well with an eighty-five to ninety percent improvement in symptoms.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: ECLIPSE TRUNION 45MM, SLOTTED, TPS CAP
• 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: 21586152
• Report Number: 1220246-2025-00904
• Device Sequence Number: 18359924
• Product Code: QHQ
• UDI-Device Identifier: 00888867276154
• UDI-Public: 00888867276154
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/08/2025

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 TRUNION 45MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-45CPC
• Device Lot Number: 22.03653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown