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

Model Number	UNIVERSAL GLENOID - INLAY LARGE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2020
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.
Event or Problem Description
It was reported that the patient needed to have a revision on his shoulder.Original dos (b)(6) 2019 for a total shoulder.Per the patient, he was swatting a fly and the plastic piece of the glenoid detached in his shoulder.The revision case was (b)(6) 2020.An ar-9121-03 and the stem (unknown part #) were removed.The case was converted to a reverse shoulder, a 42 glenopshere and cup were implanted.Patient is male, (b)(6) years.
Additional Manufacturer Narrative
Complaint confirmed as the device was explanted and returned.Slight damage was observed on the locking pegs but the cause of the event is undetermined.
Additional Manufacturer Narrative
Complaint confirmed as the device was explanted and returned.Slight damage was observed on the locking pegs but the cause of the event is undetermined.

• Brand Name: UNIVERSAL GLENOID - INLAY LARGE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11075959
• Report Number: 1220246-2020-02435
• Device Sequence Number: 3066298
• Product Code: PHX
• UDI-Device Identifier: 00888867057432
• UDI-Public: 00888867057432
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 09/02/2021

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
• Device Catalogue Number: AR-9121-03
• Device Lot Number: 17.00592
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 12/10/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 08/19/2021; 09/02/2021
• 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