MAUDE Adverse Event Report: ARTHREX, INC. 42 +4 LAT/24 GLENOSPHERE; SHOULDR PROSTH, REVERSE CONFIG

Model Number 42 +4 LAT/24 GLENOSPHERE

Device Problem Fitting Problem (2183)

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

Event Date 03/23/2023

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2023, it was reported by a sales representative via email that an ar-9564-2442-lat arthrexunivers revers modular glenoid system glenosphere would spin around the baseplate when the screw was attempting to be torqued.This was discovered during a revision reverse total shoulder procedure on (b)(6) 2023.A new glenosphere was used to complete the case.

• Brand Name: 42 +4 LAT/24 GLENOSPHERE
• Type of Device: SHOULDR PROSTH, REVERSE CONFIG
• 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: 16785318
• MDR Text Key: 313727946
• Report Number: 1220246-2023-06569
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867295742
• UDI-Public: 00888867295742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2442-LAT
• Device Lot Number: 19.02954
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2023
• Date Device Manufactured: 01/01/2020
• 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
• Patient Outcome(s): Other