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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a loosening of the pegged glenoid led to an explantation of the anatomic eclipse prosthesis and the pegged glenoid.No further information was provided.Update avoe (b)(6) 2023: it was confirmed that the initial surgery took place in 2015 in the privatklinik bethanien, 8044 zürich.After the eclipse and the pegged glenoid were explanted, these devices were replaced with devices from another manufacturer.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the image received from the field, it was noted that the arthrex eclipse¿ was explanted.Consequently, 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.Per dfu-0181-eo revision 4: '3.Loosening of the implant as a result of changed conditions in load transfer, respectively, fatigue wear or tissue reaction to the implant.Loosening is frequently a consequence of one or several of the above listed risk conditions but can also be caused by inadequate anchoring technique (see below).4.Dislocation, subluxation, or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant.".

• 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: emily shafer ; 8009337001
• MDR Report Key: 17486646
• Report Number: 1220246-2023-07461
• Device Sequence Number: 7252997
• Product Code: QHQ
• UDI-Device Identifier: 00888867060029
• UDI-Public: 00888867060029
• 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,Followup
• Report Date (Section B): 02/07/2025

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
• Device Lot Number: 1295130205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 02/07/2025
• 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