MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 47/20; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 47/20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2021

Event Type  malfunction  

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 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 (b)(6), 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).

Manufacturer Narrative

Complaint not confirmed, no abnormality was observed that may have contributed to the event.Only minor wear and abrasion were observed that are expected from an explanted device.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 47/20
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12364473
• MDR Text Key: 268081644
• Report Number: 1220246-2021-03572
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060050
• UDI-Public: 00888867060050
• Combination Product (y/n): N
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 47/20
• Device Catalogue Number: AR-9347-20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other