MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 45/17; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 45/17
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6a, d6b, g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to a patient-specific event, resulting from a traumatic fall, which subsequently led to adverse outcomes necessitating revision surgery.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 45/17
• 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: 21586172
• Report Number: 1220246-2025-00907
• Device Sequence Number: 21040940
• Product Code: QHQ
• UDI-Device Identifier: 00888867060029
• UDI-Public: 00888867060029
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: ARTHREX ECLIPSE HUMERAL HEAD, 45/17
• Device Catalogue Number: AR-9345-17
• 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: 08/29/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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