MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, BETA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 314-13-13

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 300-30-10 - equinoxe preserve stem 10mm: 5582373 300-50-45 - 4.5mm short rep plate: 5416244 310-01-47 - equinoxe, humeral head short, 47mm (beta): 5193690 315-35-00 - glnd kwire: 5665042 300-20-02 - equinox square torque define screw drive kit: 5442999.

Event Description

As reported by the equinoxe shoulder study, the 56-year-old male patient had an initial right tsa on (b)(6) 2018 and presented with polyethylene wear (with or without osteolysis), approximately 1 month(s) and 5 year(s) post-operatively on 15-nov-2023.Reviewing x-rays and patient has poly wear.Patient also has increase in pain.The outcome of this event is considered continuing, with the action taken of other - monitoring with x-ray as patient did not want to proceed with revision intervention immediately.The case report form indicates that this event is definitely related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18810107
• MDR Text Key: 336584969
• Report Number: 1038671-2024-00349
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2016
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White