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	Joint Dislocation (2374); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The explanted glenosphere was found to meet specifications.The event was most likely caused by the inserter tip fragment lodged in the glenosphere threaded hole and may have prevented the glenosphere locking screw insertion per surgery technique.
Event or Problem Description
It was reported five days after an initial left revers tsa procedure, a revision procedure took place which included the removal of the ar-9564-2436-lat glenosphere (lot: 18.00691).The original procedure took place on (b)(6) 2019.During the initial procedure the tip of the ar-9624, glenosphere inserter broke off in the glenosphere and was left implanted in the patient (case 19935-1).The explanted ar-9564-2436-lat has been returned to arthrex along with the broken tip of the ar-9624 that was located inside of it.Additional information has been requested.Additional information received on 06/03/2019: the rep stated the reason for the revision surgery was due to the patient having a dislocated and disassociated glenoshphere which was confirmed with an in-clinic x-ray.The ar-9564-2436-lat (lot: 18.00691) was removed during the revision and replaced with the exact same part and lot number.Additional information has been requested.Additional information received on 06/04/2019: the rep confirmed the dislocation was discovered during the patients follow-up appointment that occurred on (b)(6) 2019.The revision procedure was not a planned revision, and took place on (b)(6) 2019 due to component disassociation.The rep confirmed the revision procedure was completed without incident.There was no trauma noted by the patient.See copies of x-rays taken during the follow-up appointment.

• 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
• MDR Report Key: 8711330
• Report Number: 1220246-2019-01151
• Device Sequence Number: 1831355
• Product Code: PHX
• UDI-Device Identifier: 00888867295681
• UDI-Public: 00888867295681
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2436-LAT
• Device Lot Number: 18.00691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/19/2019
• 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