MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - CENTRAL SCREW 20MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERSAL GLENOID - CENTRAL SCREW 20MM
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision of an eclipse with universal glenoid was necessary due to wear of the polyethylene glenoid of the universal glenoid base plate.It was further reported that the issue cause a strong metallosis due to the metal to metal friction.The following devices were explanted during the revision surgery: cd-9341-16, eclipse head, size 41/16 tinbn coated ar-9300-41cpc eclipse trunion,41 mm tps ctd ar-9301-02 eclipse cage screw m, 35mm ar-9120-01 universal glenoid - baseplate small ar-9165-20 universal glenoid - central screw 20mm 2x unknown peripheral screws.
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.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, g3, h3, h6.Complaint allegation is confirmed based on the photos provided by the customer.Visual evaluation revealed an extracted cd-9341-16.In addition, a photo of the metallosis was also provided.The head, tinbn, has an inferior bearing surface than the standard cobalt chrome.This was likely done due to the patient having a nickel allergy.This bearing surface may have contributed to wearing the poly more quickly.The most likely cause for the reported failure can be attributed to a patient-specific event.
Event or Problem Description
Information was provided that the devices were initially implanted in 2016.It was further updated that the initial surgery was performed on (b)(6) 2017 at (b)(6) by dr (b)(6).

• Brand Name: UNIVERSAL GLENOID - CENTRAL SCREW 20MM
• 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: 18780030
• Report Number: 1220246-2024-01126
• Device Sequence Number: 4512067
• Product Code: PHX
• UDI-Device Identifier: 00888867057937
• UDI-Public: 00888867057937
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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 - CENTRAL SCREW 20MM
• Device Catalogue Number: AR-9165-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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