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

Model Number	39 +4 LAT/28 GLENOSPHERE
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-05192
• Device Sequence Number: 5832472
• Product Code: PHX
• UDI-Device Identifier: 00888867295797
• UDI-Public: 00888867295797
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/11/2022
• Date Device Manufactured: 11/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown