MAUDE Adverse Event Report: ARTHREX, INC. 42/28 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 42/28 GLENOSPHERE

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/28/2023

Event Type  Injury  

Event Description

On 3/1/2023, it was reported by a sales representative via email that a shoulder arthroplasty revision surgery took place on (b)(6) 2023 due to an infection.The surgeon removed an ar-9560-28 arthrex univers revers modular glenoid system modular baseplate, an ar-9502f-42lcpc arthrex univers revers suture cup, an ar-9564-2842 arthrex univers revers modular glenoid system glenosphere, an ar-9503l-03 arthrex univers revers humeral insert, (2) ar-9563-20 univers revers modular glenoid system peripheral locking screw, an ar-9562-28nl univers revers modular glenoid system peripheral non-locking screw, an ar-9562-40nl univers revers modular glenoid system peripheral non-locking screw, an ar-9561-25p univers revers modular glenoid system central post modula, and an ar-9501-05p univers revers humeral stem.

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.

• Brand Name: 42/28 GLENOSPHERE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16582169
• MDR Text Key: 311670692
• Report Number: 1220246-2023-06455
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867295803
• UDI-Public: 00888867295803
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 42/28 GLENOSPHERE
• Device Catalogue Number: AR-9564-2842
• Device Lot Number: 18.01737
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/21/2023
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other