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

Model Number	UNIVERSAL GLENOID INLAY SMALL
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/11/2022
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 revision surgery of a eclipse with universal glenoid was performed.No further information was provided.Update 19-jan-2022: further information were provided that the revision surgery was necessary due to an aseptic loosening.It was further reported that a progressive polyethylene abrasion with pronounced metallosis was identified as well.Therefore the shoulder prosthesis was changed to an inverse shoulder prosthesis.

• Brand Name: UNIVERSAL GLENOID INLAY SMALL
• 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: 13397023
• Report Number: 1220246-2022-04359
• Device Sequence Number: 5893144
• 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): 01/31/2022

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 SMALL
• Device Catalogue Number: AR-9121-01
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown