MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 36 +4 LAT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERS REVERS GLENO 36 +4 LAT
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	06/17/2019
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.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 that a patient had an arthrex revers system implanted on (b)(6) 2018.It was then discovered in (b)(6) 2019 that the implanted glenosphere (ar-9504s-04 / lot: 170061914) had disassociated.A revision reverse shoulder replacement procedure took place on (b)(6) 2019.During the revision procedure, the surgeon attempted to put a new glenosphere on the original implanted baseplate (ar-9120-01 / lot: 170131615), but the glenosphere would not engage.The surgeon then removed the original baseplate, and put in a new baseplate and the same new glenosphere that was attempted to use with the damaged baseplate.The components engaged normally and the case was finished.The rep stated that the patient has a history of falls and non-compliance.The explanted glenosphere is available for return, but the original baseplate was discarded by the facility's sterile processing.Additional information received on (b)(6) 2019: the rep confirmed the primary and revision procedures were performed by the same surgeon and took place at the same facility.The patient had a follow-up visit due to complaining of discomfort after having a reverse shoulder replacement on (b)(6) 2018.It is unknown when the pain/discomfort first started.An x-ray was taken during the follow-up visit and the image revealed the glenosphere had disassociated.A revision was then immediately booked for (b)(6) 2019.The surgeon implanted the following arthrex parts during the revision procedure ar-9504s-04 (lot: 18.01610) and ar-9120-01 (lot: 18.01443).The rep stated there are not any copies of x-rays available.The following arthrex parts were implanted during the primary procedure: ar-9120-01 // lot: 170131615 // qty.1, ar-9145-30 // lot: 170056012 // qty.2, ar-9165-25nl // lot: 10181270 // qty.1, ar-9501-05p // lot: 170023906 // qty.1, ar-9502f-36cpc // lot: 170076006 // qty.1, ar-9503s-06 // lot: 170084010 // qty.1, ar-9504s-04 // lot: 170061914 // qty.1, ar-9507s // lot: 10181807 // qty.1.The following arthrex parts were explanted during the revision procedure: ar-9120-01 // lot: 170131615 // qty.1, ar-9145-30 // lot: 170056012 // qty.2, ar-9165-25nl // lot: 10181270 // qty.1, ar-9504s-04 // lot: 170061914 // qty.1.Additional information received on 07/29/2019: the rep confirmed the only explanted device available to return for evaluation is ar-9504s-04 // lot: 170061914.All other explanted devices were discarded.Listed below if the full list of arthrex devices used during the revision procedure: ar-9120-01 // lot: 18.01443 // qty.: 1, ar-9145-30 // lot: 18.02032 // qty.: 2, ar-9145k // lot: 031902 // qty.: 1, ar-9165-25 // lot: 170005312 // qty.: 1, ar-9165-25nl // lot: 10265094 // qty.: 1, ar-9503s-03 // lot: 18.01806 // qty.: 1, ar-9504s-04 // lot: 18.01610 // qty.: 1, ar-9507s // lot: 10271054 // qty.: 1.

• Brand Name: UNIVERS REVERS GLENO 36 +4 LAT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8845614
• Report Number: 1220246-2019-01216
• Device Sequence Number: 2824025
• Product Code: PHX
• UDI-Device Identifier: 00888867061408
• UDI-Public: 00888867061408
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: 08/31/2022
• Device Model Number: UNIVERS REVERS GLENO 36 +4 LAT
• Device Catalogue Number: AR-9504S-04
• Device Lot Number: 170061914
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/31/2019
• 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