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

Model Number	UNIVERSAL GLENOID - BASEPLATE MEDIUM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an anatomical shoulder prosthesis with universal glenoid the base plate could not be implanted completely.The surgeon replaced the peripher and central screw without success.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update dw 31-jul-2025: further information was provided that the reported base plate was initially implanted four years ago.It was further reported that the patient underwent revision surgery 3 months ago where the inlay ar-9121-02 was revised.The patient continued to have issues and underwent the second revision on (b)(6) 2025.During the revision the initially reported event has been identified and the surgeon revised the base plate and 3 screws.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6a, d9, g3, h3, h6.The complaint allegation is confirmed.Due to device contamination, only a visual evaluation was performed.Photographic evidence provided for device ar-9120-02, batch number 18.01883, showed chipping and nicks consistent with the implantation and explantation process.Based on the available information¿which may include the returned device (if applicable), photographs, videos, event descriptions, and any additional field data¿arthrex determined the most probable cause of the reported issue.The most likely root cause may be attributed to a patient-specific event, potentially involving bone remodeling or degradation over time, device wear, or loosening from the initial implantation, as well as anatomical changes following the initial surgery.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE 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: 22771546
• Report Number: 1220246-2025-03396
• Device Sequence Number: 13041563
• Product Code: PHX
• UDI-Device Identifier: 00888867057357
• UDI-Public: (01)00888867057357(11)190501(17)240430(10)18.01883
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 04/30/2024
• Device Model Number: UNIVERSAL GLENOID - BASEPLATE MEDIUM
• Device Catalogue Number: AR-9120-02
• Device Lot Number: 18.01883
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• 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