MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID INLAY SMALL; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERSAL GLENOID INLAY SMALL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was necessary due to a subluxation.The shoulder prosthesis was changed to an inverse prosthesis.No further information received.
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.

• Brand Name: UNIVERSAL GLENOID INLAY SMALL
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: 16838379
• Report Number: 1220246-2023-06620
• Device Sequence Number: 18019573
• Product Code: PHX
• UDI-Device Identifier: 00888867057418
• UDI-Public: 00888867057418
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 04/30/2022
• Device Model Number: UNIVERSAL GLENOID INLAY SMALL
• Device Catalogue Number: AR-9121-01
• Device Lot Number: 170054911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Date Device Manufactured: 05/30/2017
• 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