MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 47/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 47/18
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one year after the implantation of a right shoulder total endo-prosthesis eclipse on (b)(6) 2016, polyethylene degradation was identified post-operatively.This resulted in a bone defect which led to a revision surgery to change the implant to an inverse prosthesis.
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.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• 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: 14337532
• Report Number: 1220246-2022-04889
• Device Sequence Number: 14786618
• Product Code: QHQ
• UDI-Device Identifier: 00888867060043
• UDI-Public: 00888867060043
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 05/09/2022

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: 10/31/2020
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• Device Catalogue Number: AR-9347-18
• Device Lot Number: 1545001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown