MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-15-04

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

Patient Problem Failure of Implant (1924)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): (b)(6): 300-30-06 - equinoxe preserve stem 6mm.(b)(6): 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6): 320-15-04 - rs glenoid plate r post aug, 8 deg, right.(b)(6): 320-46-03 - equinoxe reverse 46mm humeral liner +2.5.

Event Description

As reported by the equinoxe shoulder study, the patient had an initial tsa on (b)(6) 2020.The patient presented on 28-jun-2023 with aseptic glenoid loosening - breakage of components leading to glenoid loosening.The case report form indicates that this event is possibly related to device and/or to procedure.Outcome is continuing with instructions to watch & wait, stoke patient waiting medical clearance.

• Brand Name: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• Type of Device: PROSTHESIS, SHOULDER, NON-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: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18196994
• MDR Text Key: 328882739
• Report Number: 1038671-2023-02845
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150458
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2019
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White