MAUDE Adverse Event Report: EXACTECH, INC. SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: serial number; item number and full description; (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(6) 300-30-06 - equinoxe preserve stem 6mm.(b)(6) 320-06-42 - glenosphere 42mm.

Event Description

As reported by the exactech equinoxe shoulder study, the patient had an initial right tsa on (b)(6) 2020.The patient presented on (b)(6) 2022 with aseptic glenoid loosening and was revised to non-exactech devices on (b)(6) 2022.The case report form indicates this event is definitely related to the device and procedure.This event report was received through clinical data collection activities.Outcome: resolution date: (b)(6) 2022.

• Brand Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17711136
• MDR Text Key: 322960395
• Report Number: 1038671-2023-02200
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

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 Model Number: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2019
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention