MAUDE Adverse Event Report: ARTHREX, INC. 36/24 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	36/24 GLENOSPHERE
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that there was a primary installation of an inverse prosthesis with mgs on (b)(6) 2019.As the glenoid components are not grown in a revision surgery took place on (b)(6) 2022.The complete glenoid was removed: total glenoid side and the inlay shaft side.Implantation and conversion to cta was successful, patient is pain-free.The removed implants were not sent for clarification of a possible infection/bacteria.All tissue on the implant was removed.During revision surgery the following devices were also removed from patient: 1x ar-9560-24p lot: 5365.1x ar-9562-24nl lot: 18.00142.1x ar-9562-32nl lot: 18.00153.1x ar-9563-24 lot: 2019000255.1x ar-9563-36 lot: 18.01676.1x ar-9503s-03 lot: 19.00664.

• Brand Name: 36/24 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: 15788300
• Report Number: 1220246-2022-05749
• Device Sequence Number: 5402237
• Product Code: PHX
• UDI-Device Identifier: 00888867295667
• UDI-Public: 00888867295667
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: 06/30/2023
• Device Model Number: 36/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2436
• Device Lot Number: 18.00683
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/14/2022
• Date Device Manufactured: 07/01/2018
• 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