MAUDE Adverse Event Report: ARTHREX, INC. 36 +3 / 33 COMBO HUMERAL INSERT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	36 +3 / 33 COMBO HUMERAL INSERT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2020
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported through the surgical outcome system that a revision surgery is required due to the loosening of the prosthetic joint.No additional information provided.Additional information requested.Additional information provided 10/5/2021: the date of primary procedure was on (b)(6) 2019 for a reverse total shoulder replacement.This procedure took place at (b)(6) medical center, arthrex account # (b)(4).The date of the revision surgery was on (b)(6) 2020 for a poly swap and glenosphere exchange.This revision took place at (b)(6) medical center, arthrex account #(b)(4).The part and lot number(s) of all arthrex part(s) that were explanted during the revision are as followed: on (b)(6) 2020: glenosphere (ar-9564-2433-lat, lot 19.00014 (2024-04-30)), insert (ar-9503-3633-3, lot 19.00010 (2024-04-30)), unsure which specific screw replaced.The part and lot number(s) of all arthrex part(s) implanted during the revision are as followed: on (b)(6) 2020: univ.Rev mgs glenosphere, univ.Rev.Humeral insert, univ.Rev.Mgs peripheral screw, (qty.1).This patient underwent two separate revision(s).Case number(s) (b)(4).

• Brand Name: 36 +3 / 33 COMBO HUMERAL INSERT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12696687
• Report Number: 1220246-2021-03834
• Device Sequence Number: 11760082
• Product Code: PHX
• UDI-Device Identifier: 00888867296596
• UDI-Public: 00888867296596
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 04/30/2024
• Device Model Number: 36 +3 / 33 COMBO HUMERAL INSERT
• Device Catalogue Number: AR-9503-3633-3
• Device Lot Number: 19.00010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other