MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/04/2021
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 the patient underwent a rtsa procedure on (b)(6) 2020.A revision was then performed due to a loosened glenosphere on (b)(6) 2021 where the following devices were explanted: ar-9564-2839 lot: 19.00602; ar-9503m-06 lot: 19.04678.
Additional Manufacturer Narrative
Complaint not confirmed, the humeral insert was found to be heavily worn but relevant and undamaged critical features were found to meet specifications.The cause of the wear and of the glenosphere loosening are undetermined.

• Brand Name: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12075690
• Report Number: 1220246-2021-03327
• Device Sequence Number: 3848774
• Product Code: PHX
• UDI-Device Identifier: 00888867061279
• UDI-Public: 00888867061279
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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): 10/08/2021

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 Expiration Date: 02/28/2025
• Device Model Number: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-06
• Device Lot Number: 19.04678
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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