MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	24MM BASEPLATE, MODULAR
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/04/2022
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
On 5/4/2022, it was reported by a sales representative via phone that a patient had a right shoulder rtsa on (b)(6) 2019.Patient underwent a revision surgery due to chronic instability of the glenoid, which appeared to be worn out.However, sales representative could not confirm if any of the arthrex implanted devices had broken.Additional information received on 5/12/2022: the original procedure occurred on (b)(6) 2019 and patient underwent revision surgery on (b)(6) 2020.Both procedures were performed at the same facility and by the same surgeon.On (b)(6) 2019, an ar-9501-05p humeral stem, an ar-9502f-36cpc suture cup, an ar-9503-3633-3 humeral inserter, (2) ar-9560-24 baseplate, from different lot numbers, an ar-9561-20s central screw, an ar-9561-25s central screw, (3) ar-9563-16 peripheral locking screws, one being from a different lot number, and and ar-9564-2433 glenosphere were implanted.Sales representative cannot confirm which devices were explanted during revision surgery on (b)(6) 2020.However, during revision surgery on (b)(6) 2020, an ar-9503-3633-3c humeral inserter, an ar-9560-24 baseplate, an ar-9561-35s central screw, and ar-9563-16 peripheral locking screw, ar-9563-20 peripheral locking screw, ar-9563-24 peripheral locking screw, an ar-9563-32 peripheral locking screw, and an ar-9564-2433-lat glenosphere were implanted.

• Brand Name: 24MM BASEPLATE, MODULAR
• 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: 14573302
• Report Number: 1220246-2022-05009
• Device Sequence Number: 20103214
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: 00888867296411
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/02/2022

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: 07/31/2024
• Device Model Number: 24MM BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 7037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/02/2022
• Date Device Manufactured: 08/01/2019
• 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