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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907)
Date of Event	12/11/2024
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
On (b)(6) 2024, it was reported by the patient via phone that the patient had the ar-9345-17 arthrex eclipse¿ humeral head, 45/17 explanted from the patient's right shoulder for a revision procedure on (b)(6) 2024 due to a bad allergic reaction with the product.The patient had visible round rashes spreading from the ears, face, inner elbows, and upper chest and then went to the patient's right shoulder, stomach, and inner ear canal and became a systemic rash causing bowel issues.The original procedure for the right shoulder arthroscopic stemless replacement was on (b)(6) 2022.The original and revision procedures were performed with the same surgeon in the same facility.The patient then inquired about the material composition of the ar-9345-17t arthrex eclipse¿ titanium humeral head 45/17 implanted in the revision surgery.The patient would like to know if the titanium has nickel or other metals.The patient has a nickel allergy and is concerned about having another reaction like before.
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, 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: 21102517
• Report Number: 1220246-2025-09274
• Device Sequence Number: 8818580
• Product Code: QHQ
• UDI-Device Identifier: 00888867060029
• UDI-Public: 00888867060029
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 12/11/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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