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	Pain (1994)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 7/3/2024, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry has been scheduled for revision surgery on (b)(6) 2024 due to failed implants and the patient is experiencing pain.The patient underwent original surgery on (b)(6) 2023 for a univers revers implant system.The patient will see the surgeon on (b)(6) 2024 to discuss the revision surgery of a shoulder hemiarthroplasty versus a revers total shoulder arthroplasty.No further information has been provided.Additional information received on 7/30/2024: the patient implants that will be revised on (b)(6) 2024 are an ar-9502f-36rcpc arthrex univers revers suture cup, 36, an ar-9503s-06 arthrex univers revers humeral insert small / 36 / +6, two ar-9562-32nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 32 mm, an ar-9562-40nl univers revers modular glenoid system, peripheral screw, non-locking 4.5 x 40 mm, an ar-9563-16 univers revers modular glenoid system, peripheral screw, locking 5.5 x 16 mm, an ar-9563-20 univers revers modular glenoid system, peripheral screw, locking 5.5 x 20 mm, an ar-9564-2436-lat arthrex univers revers modular glenoid system gleno sphere 36 +4 lat / 24, an ar-9580-2420s univers revers modular glenoid system augmented base plate 24 mm, 20° full, an, and an ar-9582-25 modular post for augmented mgs baseplate 25 mm.
Event or Problem Description
Additional information received on 11/4/2024: on (b)(6) 2024, the patient's implants were converted from failed revers to a hemiarthroplasty due to the displaced glenoid components from the broken screws.At this time, it is unknown which arthrex products from the original surgery on (b)(6) 2023 were explanted during the revision surgery on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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: 19907231
• Report Number: 1220246-2024-07028
• Device Sequence Number: 7080269
• Product Code: PHX
• UDI-Device Identifier: 00888867341845
• UDI-Public: 00888867341845
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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 Model Number: MODULAR POST, 25MM
• Device Catalogue Number: AR-9582-25
• Device Lot Number: 1230942206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided; 06/06/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 12/02/2024; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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
• Patient Sex: Unknown