MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2022
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
On 9/28/2022, it was reported by a sales representative via email that an a patient underwent a reverse modular shoulder procedure on (b)(6) 2020.During this procedure an ar-9501-13s apex humeral stem, an ar-9502f-39lcpc suture cup, an ar-9503m-03 humeral insert, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, an ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere, were successfully implanted.Two years later, on (b)(6) 2022, patient underwent a revision reverse total shoulder procedure because the central and peripheral screws broke off the baseplate.Additional information received on 9/30/2022: during revision surgery on (b)(6) 2022, an ar-9560-28-4 modular baseplate, an ar-9561-35s central screw, an ar-9563-36 peripheral locking screw, and ar-9563-40 peripheral locking screw, and an ar-9564-2839-lat glenosphere were removed.Procedure was completed by implanting an ar-9502-39arca univers revers ca humeral head adapter from lot number 18.00756 and an ar-9550-19rca univers revers ca humeral head from lot number 10248799 were implanted.
Additional Manufacturer Narrative
Review of this complaint confirmed the event summary code selection and an investigation including a product history review was performed as required.The complaint device was not returned for investigation, however, picture(s) of the complaint device were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was not able to be determined.The investigation did not change the potential harm(s) identified.Complaint trending for this event will be performed per wi-000100100.

• Brand Name: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• 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: 15615576
• Report Number: 1220246-2022-05626
• Device Sequence Number: 5810857
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: 00888867061255
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/29/2022

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: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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