MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE; SHOULDR PROSTH, REVERSE CONFIG

Model Number UNIVERSAL GLENOID - INLAY LARGE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

On 6/2/2023, it was reported by a patient that an arthrex eclipse stemless humeral implant and convertible universal glenoid products were implanted during a shoulder replacement procedure on (b)(6) 2023.The patient is experiencing a possible unspecified reaction.No further information has been provided.Additional information received.

• Brand Name: UNIVERSAL GLENOID - INLAY LARGE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17199320
• MDR Text Key: 317845890
• Report Number: 1220246-2023-06991
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057432
• UDI-Public: 00888867057432
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2023

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
• Device Operator: Health Professional
• Device Model Number: UNIVERSAL GLENOID - INLAY LARGE
• Device Catalogue Number: AR-9121-03
• Device Lot Number: 22.01758
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/26/2023
• Date Device Manufactured: 08/01/2022
• 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