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	Failure of Implant (1924)
Date of Event	12/18/2018
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 device was reported to have been discarded.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 approximately one and a half weeks after having a primary reverse shoulder arthroplasty procedure, the patient's glenosphere disassociated post-op.The following arthrex parts were implanted during the primary procedure that took place on (b)(6) 2018: ar-9507s // lot: 10232680, ar-9165-25nl // lot: 10221985, ar-9120-03 // lot: 18.00430, ar-9145-30 // lot: 18.00677, ar-9145-24 // lot: 18.00574, ar-9504l-04 // lot: 18.00719, ar-9501-06p // lot: 170151305, ar-9502f-42cpc // lot: 170161207, ar-9550-06 // lot: 18.00355, ar-9503l-03c // lot: 18.00110.It is unknown if the patient was experiencing any pain or discomfort.The disassociation was discovered approximately one and a half weeks post-op during physical therapy.A revision procedure was performed on (b)(6) 2018.The rep stated copies of x-ray's are not available, nor were any pictures taken.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The following arthrex parts were explanted during the revision procedure: ar-9504l-04 // lot: 18.00719, ar-9550-06 // lot: 18.00355, ar-9503l-03c // lot: 18.00110.The following arthrex parts were implanted during the revision procedure: ar-9504l-04 // lot: 18.00719, ar-9550-06 // lot: 160147410, ar-9503l-03c // lot: 170005110.Additional information received on 07/18/2019: the rep confirmed all explanted devices were discarded.

• 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: 8861324
• Report Number: 1220246-2019-01227
• Device Sequence Number: 13953380
• Product Code: PHX
• UDI-Device Identifier: 00888867061347
• UDI-Public: 00888867061347
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 07/15/2019
• Initial Report FDA Received Date: 08/05/2019
• 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