MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 49/18; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 49/18
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	07/22/2024
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
It was reported that on pictures it was found that after an implantation in november 2007 the coating of the pan is abraded and a metallosis is suspected.No information provided by the customer.Update dw 01-aug-2024: further information was provided that the prosthesis was implanted in agatharied from prof.Brunner in october 2007.3 years ago the prosthesis started to making noises in specific movements.Prof.Brunner has diagnosed a wear of the poly with a metallosis and osteolysen.The surgeon advised the patient to clarify the event with an additional arthroscopy.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 49/18
• 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: 19967189
• Report Number: 1220246-2024-07154
• Device Sequence Number: 12964301
• Product Code: QHQ
• UDI-Device Identifier: 00888867060067
• UDI-Public: 00888867060067
• 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,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 11/30/2011
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 49/18
• Device Catalogue Number: AR-9349-18
• Device Lot Number: 0651018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 02/25/2025
• 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