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

Model Number UNIVERSAL GLENOID - CENTRAL SCREW 20MM

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/06/2024

Event Type  Injury  

Event 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.

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.

• Brand Name: UNIVERSAL GLENOID - CENTRAL SCREW 20MM
• Type of Device: 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
• MDR Text Key: 336285902
• Report Number: 1220246-2024-01126
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNIVERSAL GLENOID - CENTRAL SCREW 20MM
• Device Catalogue Number: AR-9165-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other