MAUDE Adverse Event Report: ARTHREX, INC. 5.5X16MM PERIPHERAL SCREW, LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	5.5X16MM PERIPHERAL SCREW, LOCKING
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05/28/2025, a clindex notification was received indicating that a patient listed on the shoulder arthroplasty registry had experienced a deep infection.On (b)(6) 2025, the patient presented with increased swelling and aching in the operative shoulder, with symptoms reported to have begun about three to four weeks prior to the clinic visit on (b)(6) 2025.The patient was referred for synovasure testing on (b)(6) 2025, and a visit on (b)(6) 2025 confirmed the infection.A revision was subsequently performed on (b)(6) 2025.The event was indicated as unrelated to the univers revers apex implanted on (b)(6) 2024.Additional information received on 6/20/2025: during the revision surgery on (b)(6) 2025, an ar-9501-11s univers revers apex humeral stem, an ar-9502f-36cpc arthrex univers revers suture cup, an ar-9503-3639-3 univers revers modular glenoid system combo humeral insert, two ar-9563-16 univers revers modular glenoid system peripheral locking screw, an ar-9563-24 univers revers modular glenoid system peripheral locking screw, an ar-9563-32 univers revers modular glenoid system peripheral locking screw, an ar-9564-2439-lat arthrex univers revers modular glenoid system glenosphere, an ar-9580-2410-2s univers revers modular glenoid system augmented baseplate, and an ar-9582-25 modular post for augmented mgs baseplate were explanted.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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.Per dfu-0189-eu-01-eo g.Contraindications - 4.Any active infection or blood supply limitations.K warning -22.An infection in an artificial joint may lead to implant removal.The most likely cause for the reported failure can be attributed to a patient-specific event due to a deep infection, resulting in a revision/second surgery.

• Brand Name: 5.5X16MM PERIPHERAL SCREW, LOCKING
• 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: 22521369
• Report Number: 1220246-2025-02907
• Device Sequence Number: 9231500
• Product Code: PHX
• UDI-Device Identifier: 00888867296800
• UDI-Public: (01)00888867296800(11)240612(17)290531(10)15272693
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 5.5X16MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-16
• Device Lot Number: 15272693
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown