MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	UNIVERSAL GLENOID - INLAY LARGE PLUS
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
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 patient underwent a revision shoulder procedure on (b)(6) 2021 where an arthrex implant was removed.No further details, additional information has been requested.Additional information provided 08/19/2021: the date of the primary procedure was on (b)(6) 2021 for a left total shoulder arthroplasty.This procedure took place at (b)(6) surgery center, arthrex account # (b)(4).Revision for a left anatomic total shoulder arthroplasty to reverse shoulder arthroplasty took place at arthrex account # (b)(4) on (b)(6) 2021 where the following devices were explanted: ar-9301-02 (20.00960); ar-9301-47cpc (19.04096); ar-9347-20 (2797, 47/20); ar-9121-06 (17.01402).
Additional Manufacturer Narrative
The complaint is not confirmed.Allegations states there was loosening of the humeral implants.The ar-9121-06 is a glenoid implant.Damage and abrasion were observed on the device, the cause of which is undetermined.No further abnormality was observed on the device that may have contributed to the humeral loosening.

• Brand Name: UNIVERSAL GLENOID - INLAY LARGE PLUS
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12364477
• Report Number: 1220246-2021-03573
• Device Sequence Number: 11791240
• Product Code: PHX
• UDI-Device Identifier: 00888867057463
• UDI-Public: 00888867057463
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: UNIVERSAL GLENOID - INLAY LARGE PLUS
• Device Catalogue Number: AR-9121-06
• Device Lot Number: 17.01402
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown