MAUDE Adverse Event Report: ARTHREX, INC. 36 +4 LAT/24 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	36 +4 LAT/24 GLENOSPHERE
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Foreign Body In Patient (2687)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that a patient under went a primary reverse procedure and fell 14 months later, post operative.Immediately after the fall, patient experience shoulder pain radiographs showed evidence of a broken ar-9563-32 peripheral locking screw, a shifter baseplate and glenosphere.A revision surgery took place on (b)(6) 2022 for removal of ar-9563-32 peripheral locking screw, which was only partially removed, surgeon made the decision to leave a portion of the broken screw, as attempting to retrieve it may have resulted in additional bone loss.An ar-9563-28 peripheral locking screw, an ar-9561-25s central screw, an ar-9560-24-2 baseplate, an ar-9564-2436-lat gleno sphere, and an ar-9503s-06 humeral insert were all explanted during revision reverse tsa procedure on (b)(6) 2022.Surgeon completed case implanting new glenoid implants.
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: 36 +4 LAT/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: 14547426
• Report Number: 1220246-2022-04984
• Device Sequence Number: 6774125
• Product Code: PHX
• UDI-Device Identifier: 00888867295681
• UDI-Public: 00888867295681
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/31/2022

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: 12/31/2024
• Device Model Number: 36 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2436-LAT
• Device Lot Number: 19.02002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/31/2022
• Date Device Manufactured: 01/01/2020
• 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