MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 39/16; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 39/16
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
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
On (b)(6) 2022, it was reported by a sales representative via email that an ar-9301-01 eclipse cage screw, an ar-9301-39cpc eclipse trunion, and an ar-9339-16 eclipse humeral head were implanted.The surgeon deemed it necessary to explant the eclipse trunion, cage screw, and humeral head, and upgrade to apex stemmed implant due to bone quality issues.This was discovered during an anatomic total shoulder replacement procedure on (b)(6) 2022.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 39/16
• 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: 15842785
• Report Number: 1220246-2022-05795
• Device Sequence Number: 5846090
• Product Code: QHQ
• UDI-Device Identifier: 00888867059962
• UDI-Public: 00888867059962
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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: 08/31/2025
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 39/16
• Device Catalogue Number: AR-9339-16
• Device Lot Number: 2038001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/22/2022
• Date Device Manufactured: 09/01/2020
• 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