MAUDE Adverse Event Report: ARTHREX, INC. 39 +4 LAT/28 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 39 +4 LAT/28 GLENOSPHERE

Device Problem Use of Device Problem (1670)

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

Event Date 06/20/2022

Event Type  Injury  

Event Description

On 6/21/2022, it was reported by a sales representative via email that an ar-9564-2839-lat glenosphere was implanted over a 24mm taper mgs base plate.This was discovered during a rts revision procedure on (b)(6) 2022.Additional information received on 6/21/2022.The original surgery was performed on (b)(6) 2022 and an ar-9564-2839-lat glenosphere was implanted.On the same day, (b)(6) 2022, a revision surgery took place because the wrong device was implanted.During revision surgery, surgeon explanted ar-9564-2839-lat glenosphere and replaced it with an ar-9564-2439-lat glenosphere.Both surgeries were performed at the same facility with the same surgeon.Case was completed successfully and no further issues has been reported.

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: 39 +4 LAT/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: 14976199
• MDR Text Key: 295604832
• Report Number: 1220246-2022-05192
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867295797
• UDI-Public: 00888867295797
• 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: 07/11/2022

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 Model Number: 39 +4 LAT/28 GLENOSPHERE
• Device Catalogue Number: AR-9564-2839-LAT
• Device Lot Number: 20.02564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/11/2022
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other