MAUDE Adverse Event Report: ARTHREX, INC. HUM INSERT S/36+3 TO FIT IN 36 CUP CONST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUM INSERT S/36+3 TO FIT IN 36 CUP CONST
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); Joint Dislocation (2374)
Date of Event	04/24/2020
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 the patient had an initial reverse shoulder procedure with modified glenoid system in (b)(6) 2019.The patient had recently undergone a revision procedure on (b)(6) 2020 due to pain and construct dislocation.At the (b)(6) revision, the humeral insert was explanted and a spacer and new insert were implanted.The (b)(6) 2020 revision was reported under case (b)(4).On (b)(6) 2020, the patient had a third procedure due to neuropathy; the following devices were all explanted: implants: ar-9503s-03c (lot 19.00210), ar-9555-06 (lot 16.01037), ar-9564-2436-lat (lot 19.00689) and ar-9560-24 (lot 02191932) and 4 screws: ar-9563-16, ar-9563-28 (qty2) and ar-9563-20 to complete the procedure the surgeon implanted the following devices: ar-9502-36arca (lot 18.00755) and ar-9550-19rca (lot 10071328).

• Brand Name: HUM INSERT S/36+3 TO FIT IN 36 CUP CONST
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10074335
• Report Number: 1220246-2020-01839
• Device Sequence Number: 16868867
• Product Code: PHX
• UDI-Device Identifier: 00888867061309
• UDI-Public: 00888867061309
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 06/30/2024
• Device Model Number: HUM INSERT S/36+3 TO FIT IN 36 CUP CONST
• Device Catalogue Number: AR-9503S-03C
• Device Lot Number: 19.00210
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/20/2020
• 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