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	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the prosthesis had to be removed after 5 years as the glenoid sphere became loosened.No further information received.Update dw 11-mar-2024: further information were provided that only the glenosphere became loosened.The plate and screws did not have any issues but were replaced during the revision including the inlay and the glenosphere.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9165-20 batch 170156713 was received for investigation.Functional testing doesn't apply to this device.The visual inspection revealed that the hex geometry was damaged.The most likely cause of the reported failure is a particular patient event.According to dfu-0189-1 at revision 0.Precautions.7.Deformation of the operative site, which can prevent or impede anchoring of the implant.9.Allergic reactions to implant materials.

• 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: 18905952
• Report Number: 1220246-2024-01484
• Device Sequence Number: 18114658
• Product Code: PHX
• UDI-Device Identifier: 00888867057937
• UDI-Public: 00888867057937
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142863
• 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,Followup
• Report Date (Section B): 09/17/2024

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: 01/31/2023
• Device Model Number: UNIVERSAL GLENOID - CENTRAL SCREW 20MM
• Device Catalogue Number: AR-9165-20
• Device Lot Number: 170156713
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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