MAUDE Adverse Event Report: ARTHREX, INC. 25MM CENTRAL SCREW, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	25MM CENTRAL SCREW, MODULAR
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930)
Date of Event	09/18/2018
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) 2022, it was reported through the surgical outcome system that a revision surgery is required due to a deep infection.The date of the primary procedure was on (b)(6) 2017 for a left reverse total shoulder replacement were an univers revers, glenosphere size (36mm), glenosphere offset (4mm lateral), stem fixation (pressfit), stem size (6), and suturecup (neutral) was implanted.No additional information provided.Additional information requested.Additional information provided 1/20/2022: the first complication was reported on (b)(6) 2018 for a shoulder infection.The date of the revision procedure was (b)(6) 2019 for a reverse arthroplasty with removal of antibiotic spacer.An ar-9560-24-4 and an ar-9561-25s were explanted.Device(s) were discarded.A second complication was reported on (b)(6) 2019 due to a patient fall, resulting in a periprosthetic fracture.This complication was treated with a brace.

• Brand Name: 25MM CENTRAL SCREW, MODULAR
• 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: 13471412
• Report Number: 1220246-2022-04407
• Device Sequence Number: 2084989
• Product Code: PHX
• UDI-Device Identifier: 00888867296565
• UDI-Public: 00888867296565
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 25MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-25S
• Device Lot Number: 155539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown