MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 39 + 4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 39 + 4 LAT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2021
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
It was reported that a reverse total shoulder was performed on (b)(6), 2021.The index procedure was without complications and the ar-9504m-04 glenosphere was implanted utilizing the indicated techniques and check of morse taper engagement.It was discovered during a routine visit via a follow-up x-ray that the glenosphere did not appear to be seated properly.On (b)(6) 2021 the patient was brought back to the operating room for a revision surgery.During the revision surgery, the glenosphere was found to no longer be engaged.The surgeon felt that the original glenosphere may have wedged into the baseplate on the original operation.The decision was made to implant a new glenosphere of the same size.After impaction, the morse taper was again checked in multiple plains and felt to be engaged.A new suture cup was then placed along with a new poly insert and the patient was taken to the recovery room without complications.

• Brand Name: UNIVERS REVERS GLENO 39 + 4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872455
• Report Number: 1220246-2021-03169
• Device Sequence Number: 10993513
• Product Code: PHX
• UDI-Device Identifier: 00888867061378
• UDI-Public: 00888867061378
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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 Model Number: UNIVERS REVERS GLENO 39 + 4 LAT
• Device Catalogue Number: AR-9504M-04
• Device Lot Number: 19.01011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other