MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2021
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 patient underwent a revision shoulder procedure on (b)(6) 2021 where an arthrex implant was removed.No further details, additional information has been requested.Additional information provided 8/19/2021: the date of the primary procedure was on (b)(6)2021 for a left total shoulder arthroplasty.This procedure took place at gateway surgery center, arthrex account # (b)(4).Revision for a left anatomic total shoulder arthroplasty to reverse shoulder arthroplasty took place at arthrex account # (b)(4)on (b)(6) 2021 where the following devices were explanted: ar-9301-02 (20.00960); ar-9301-47cpc (19.04096); ar-9347-20 (2797, 47/20); ar-9121-06 (17.01402).
Additional Manufacturer Narrative
Complaint not confirmed, no abnormality was observed that may have contributed to the event.Only minor wear and abrasion were observed that is expected from an explanted device.

• Brand Name: ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12364462
• Report Number: 1220246-2021-03571
• Device Sequence Number: 17172770
• Product Code: QHQ
• UDI-Device Identifier: 00888867276161
• UDI-Public: 00888867276161
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 10/01/2021

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: 03/31/2025
• Device Model Number: ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP
• Device Catalogue Number: AR-9301-47CPC
• Device Lot Number: 19.04096
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other