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

Model Number	UNIVERSAL GLENOID INLAY SMALL
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/08/2019
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 patient underwent an insertion of an eclipse prosthesis with universal glenoid on (b)(6) 2016.After two years the ar-9121-01 glenoid inlay is partly rubbed and damaged.The patient was reported to have been doing well after surgery with a normal healing process.The patient began complaining about pain spreading to the ventral upper arm.He had this pain for about 4 weeks prior to (b)(6) 2019.The patient experienced no trauma.The patient underwent pain medication but there was no improvement.It was reported that the patient had no fever with relation to this incident.On (b)(6) 2019 there was a revision surgery where the pe inlay was exchanged and in addition ar-9343-18 humeral head was exchanged also.Update (b)(6) 2019: ar-9343-18 was exchanged because this needed to be removed for the exchange of the inlay.Revision surgery was finished successfully.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the interior surface of the glenoid had scratches and wear marks.One corner appears to be heavily worn and is cracking and chipping.The outside surface (peg side), show no marks of damage.The most likely caused is the wear and tear between the glenoid and the humeral head.

• 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
• MDR Report Key: 8495649
• Report Number: 1220246-2019-01011
• Device Sequence Number: 1634032
• Product Code: PHX
• UDI-Device Identifier: 00888867057418
• UDI-Public: 00888867057418
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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 Model Number: UNIVERSAL GLENOID INLAY SMALL
• Device Catalogue Number: AR-9121-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 08/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other