MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 43/16; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 43/16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was necessary on (b)(6) 2016 after the initial implantation on (b)(6) 2013 due to a broke out glenoid.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update dw 24-sep-2024: further information was provided that the customer has removed the glenoid arthroscopic.It was then further reported that due to an omarthrose an additional surgery was performed and an inverse shoulder-tep was implanted.
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: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• 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: 20266283
• Report Number: 1220246-2024-07771
• Device Sequence Number: 20898335
• Product Code: QHQ
• UDI-Device Identifier: 00888867060005
• UDI-Public: (01)00888867060005(11)110404(17)140930(10)0942011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 05/27/2025

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 Expiration Date: 09/30/2014
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Device Catalogue Number: AR-9343-16
• Device Lot Number: 0942011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/24/2024; 05/12/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/07/2024; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2011
• 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