MAUDE Adverse Event Report: ARTHREX, INC. MODULAR POST, 25MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	MODULAR POST, 25MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/11/2024
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) 2024, it was reported by a sales representative via (b)(4) that an ar-9660-r central post extractor got stuck in the implant during implant removal.This was discovered during a revision reverse total shoulder procedure on (b)(6) 2024.No further information was reported.Additional information received on 1/31/2024: the original procedure occurred on (b)(6) 2021.Due to pain, the patient underwent revision surgery.During the revision surgery on 1/11/2024, an ar-9503s-03 humeral insert, an ar-9555-09 univers revers spacer, an ar-9563-16 peripheral locking screw, an ar-9563-20 peripheral locking screw, an ar-9563-24 peripheral locking screw, an ar-9563-28 peripheral locking screw, an ar-9564-2436 glenosphere, an ar-9580-2410-2 baseplate, and an ar-9582-25 modular post were explanted.Only an ar-9501-10s univers revers apex stem and an ar-9502f36rcpc suture cup remained from the original surgery.To complete the revision surgery, an ar-9503s-03c humeral insert, an ar-9555-12 univers revers spacer, an ar-9560-24-4 baseplate, an ar-9561-30s central screw, an ar-9563-16 peripheral locking screw, an ar-9563-20 peripheral locking screw, (2) ar-9563-28 peripheral locking screw, and an ar-9564-2436-inf glenosphere were successfully implanted.The case was not delayed, and no further issues were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: MODULAR POST, 25MM
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: jared engle ; 8009337001
• MDR Report Key: 18696474
• Report Number: 1220246-2024-00937
• Device Sequence Number: 18270044
• Product Code: PHX
• UDI-Device Identifier: 00888867341845
• UDI-Public: 00888867341845
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 07/31/2025
• Device Model Number: MODULAR POST, 25MM
• Device Catalogue Number: AR-9582-25
• Device Lot Number: 04522008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Other
• Patient Sex: Unknown