MAUDE Adverse Event Report: ARTHREX, INC. 33/24 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	33/24 GLENOSPHERE
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It has been reported that a patient was undergoing a revision surgery.Sales rep reported while procedure was in progress.Details to be provided after procedure.Additional information obtained 07/20/2020: patient initially underwent a revers total shoulder procedure (b)(6) 2019.Patient began experiencing post op pain.An x-ray revealed a possible loosening of the glenoid unit.A ct was performed to confirm.The patient suffered no known or reported trauma.On (b)(6) 2020 the same surgeon performed a revision at a different facility.During the revision the following original implants were explanted: ar-9564-2433, glenosphere, lot 18.01946, ar-9560-24, univers revers modular baseplate, lot 7037/7041, ar-9501-05p, univers revers implant stem modular, lot 19.00135, ar-9502f-36cpc, univers revers suture cup, lot 19.02069, ar-9503-3633-3, humeral insert, lot 19.00009ar-9561-25s, modular central screw, lot 6799, ar-9563-16 (qty 3), locking screw, lot 19.00568/2019001684.The devices will be returned for evaluation.
Additional Manufacturer Narrative
Complaint not confirmed.No abnormality was observed on the device that may have contributed to the event.

• Brand Name: 33/24 GLENOSPHERE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10366791
• Report Number: 1220246-2020-01999
• Device Sequence Number: 3246746
• Product Code: PHX
• UDI-Device Identifier: 00888867295643
• UDI-Public: 00888867295643
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 01/31/2024
• Device Model Number: 33/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2433
• Device Lot Number: 18.01946
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other