MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS GLENO 42; SHOULDR PROSTH, REVERSE CONFIG

Model Number UNIVERS REVERS GLENO 42

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 03/06/2024

Event Type  Injury  

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.

Event 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.

• Brand Name: UNIVERS REVERS GLENO 42
• 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: 18905868
• MDR Text Key: 337687087
• Report Number: 1220246-2024-01483
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061330
• UDI-Public: 00888867061330
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: UNIVERS REVERS GLENO 42
• Device Catalogue Number: AR-9504L
• Device Lot Number: 170017313
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2017
• 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