MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 42 +4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 42 +4 LAT
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2019
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.It was reported that the facility is not releasing the device.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported the patient had a primary reverse total shoulder procedure on (b)(6) 2019.The patient returned to the or for a revision procedure on (b)(6) 2019 due to the implanted glenosphere disassociating from the baseplate.During the original procedure, the central screw depth gauge was used to ensure that the central screw was fully seated.After glenosphere impaction, the glenosphere forceps were used in multiple planes to ensure engagement of the morse taper.During the revision procedure the original glenosphere (ar-9120-02 / lot: 18.01057) and baseplate (ar-9504l-04 / lot: 18.00719) were explanted, and the surgeon implanted a mgs baseplate (ar-9560-28-2 / lot: 5642) and glenosphere (ar-9564-2842-lat / lot: 18.00802) in its place.The primary and revision procedure were performed by the same surgeon, and took place at the same facility.The following arthrex parts were implanted during the primary procedure: ar-9120-02 // lot: 18.01057 // qty.: 1.Ar-9145-24 // lot: 18.00674 // qty.: 1.Ar-9145-30 // lot: 18.01275 // qty.: 1.Ar-9165-20nl // lot: 10247862 // qty.: 1.Ar-9501-12p // lot: 18.00906 // qty/: 1.Ar-9502f-42cpc // lot: 160037703 // qty.: 1.Ar-9503l-03c // lot: 150044008 // qty.: 1.Ar-9504l-04 // lot: 18.00719 // qty.: 1.Ar-9550-06 // lot: 18.00623 // qty.: 1.The following arthrex parts were implanted during the revision procedure: ar-9503l-03c // lot: 18.00561 // qty.: 1.Ar-9550-06 // lot: 18.00990 // qty.: 1.Ar-9560-28-2 // lot: 5642 // qty.: 1.Ar-9561-30s // lot: 6227 // qty.: 1.Ar-9563-16 // lot: 2019000253 // qty.: 2.Ar-9563-24 // lot: 2019001686 // qty.: 1.Ar-9563-28 // lot: 2019001343 // qty.: 1.Ar-9564-2842-lat // lot: 18.00802 // qty.: 1.Additional information received on 10/08/219: the rep reported the disassociation was first discovered from x-rays taken during an office visit on (b)(6) 2019.The rep is following up with the surgeon to discuss if the cause of the disassociation is known.The bone quality was hard.The rep stated the explanted devices were sent to pathology, and will not be returning to arthrex for evaluation.The following list is all of the arthrex parts that were explanted during the revision procedure: ar-9120-02 // lot: 18.01057, ar-9504l-04 // lot: 18.00719, ar-9145-24 // lot 18.00674, ar-9145-30 // lot 18.01275, ar-9165-20nl // lot 10247862, ar-9503l-03c // lot 150044008, ar-9550-06 // lot 18.00623.

• Brand Name: UNIVERS REVERS GLENO 42 +4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9254829
• Report Number: 1220246-2019-01379
• Device Sequence Number: 2549880
• Product Code: PHX
• UDI-Device Identifier: 00888867061347
• UDI-Public: 00888867061347
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 07/31/2023
• Device Model Number: UNIVERS REVERS GLENO 42 +4 LAT
• Device Catalogue Number: AR-9504L-04
• Device Lot Number: 18.00719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/30/2019
• 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