MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 41/16; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 41/16

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

Patient Problem No Code Available (3191)

Event Date 11/27/2019

Event Type  Injury  

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.

Event Description

It was reported that the patient (female, (b)(6) years), had an eclipse total shoulder on (b)(6) 2016.Due to a subsequent torn rotator cuff, she needed to have a reverse total shoulder on (b)(6) 2019.Reporter stated that the torn rotator cuff was not due to product malfunction.Removed from the patient was ar-9341-16, ar-9300-41cpc and ar-9301-01.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 41/16
• Type of Device: 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: 9473749
• MDR Text Key: 184822696
• Report Number: 1220246-2019-01496
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867059986
• UDI-Public: 00888867059986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 41/16
• Device Catalogue Number: AR-9341-16
• Device Lot Number: 1295122505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1