MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY MEDIUM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERSAL GLENOID - INLAY MEDIUM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery 3 months ago, the specific date is unknown, where the inlay ar-9121-02 was revised as it became loose.A second revision was later performed which is handled in (b)(4).
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UNIVERSAL GLENOID - INLAY MEDIUM
• 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: 22772084
• Report Number: 1220246-2025-03402
• Device Sequence Number: 21167690
• Product Code: PHX
• UDI-Device Identifier: 00888867057425
• UDI-Public: 00888867057425
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: UNIVERSAL GLENOID - INLAY MEDIUM
• Device Catalogue Number: AR-9121-02
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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