MAUDE Adverse Event Report: UNIVERSAL GLENOID - INLAY MEDIUM UNIVERSAL GLENOID - INLAY MEDIUM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number AR-9121-02

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Abrasion (1689); Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 06/22/2021

Event Type  malfunction  

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 performed due to an aseptic loosening of the device and a progressive polyethylene abrasion with pronounced metallosis.The complete shoulder prosthesis including humerus and glenoid components was changed to inverse shoulder prosthesis.

Manufacturer Narrative

The reason for this supplemental submission is an update to change device part number from ar-9120-02 to ar-9121-02.

• Brand Name: UNIVERSAL GLENOID - INLAY MEDIUM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): UNIVERSAL GLENOID - INLAY MEDIUM; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12231613
• MDR Text Key: 263811462
• Report Number: 1220246-2021-03433
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057357
• UDI-Public: 00888867057357
• Combination Product (y/n): N
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: AR-9121-02
• Device Catalogue Number: AR-9120-02
• Device Lot Number: 2501243304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Patient Sequence Number: 1