MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNIVERSAL GLENOID - INLAY LARGE PLUS

Device Problem Material Erosion (1214)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/21/2021

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.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.

Event Description

It was reported that a revision surgery was necessary as the glenoid component abraded.The shoulder prosthesis was changed to an inverse prosthesis.No further information received.

• Brand Name: UNIVERSAL GLENOID - INLAY LARGE PLUS
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12300879
• MDR Text Key: 265973654
• Report Number: 1220246-2021-03507
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057463
• UDI-Public: 00888867057463
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K182039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: UNIVERSAL GLENOID - INLAY LARGE PLUS
• Device Catalogue Number: AR-9121-06
• Device Lot Number: 1031006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other