MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 45/17; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 45/17
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a revision surgery was necessary due to a progressive polyethylene degradation with metallosis.No further information was provided.
Additional Manufacturer Narrative
The complaint is not confirmed.The complaint device was not returned.Photographs were provided of (1) explanted ar-9345-17.Upon inspection of the photographs, the occurrence of a revision surgery was noted, but the contribution of the device to the complaint could not be determined since the complaint does not claim any failure of part number ar-9345-17 and no further information was provided.
Additional Manufacturer Narrative
The complaint is not confirmed.The complaint device was not returned.Photographs were provided of (1) explanted ar-9345-17.Upon inspection of the photographs, the occurrence of a revision surgery was noted, but the contribution of the device to the complaint could not be determined since the complaint does not claim any failure of part number ar-9345-17 and no further information was provided.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 45/17
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13839585
• Report Number: 1220246-2022-04621
• Device Sequence Number: 19997103
• 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,Followup
• Report Date (Section B): 12/18/2024

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: 1295152207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 12/02/2024
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 07/28/2022; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown