MAUDE Adverse Event Report: EXACTECH, INC. SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-35-04

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/15/2023

Event Type  Injury  

Event Description

As reported, approximately 14 days post op initial right tsa, this 53 y/o male patient was revised.The patients glenoid side construct was fractured off of the glenoid.Surgeon does not know what caused it to fracture at this time.All the components listed in this report were removed from the patient.The patient was then revised to a hemi shoulder.The patient still has the exactech humeral stem from the original surgery.They now also have a replicator plate, break off screw, and humeral head.These are part of the hemi construct.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.Product not returning - hospital policy.

Manufacturer Narrative

Section h10: (h3) pending evaluation: (d10) concomitant device(s): (b)(6) - 320-10-05 - equinoxe reverse tray adapter plate tray +5.(b)(6) - 320-15-05 - eq rev locking screw.(b)(6) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 20-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6) - 320-31-40 - glenosphere, 40mm.(b)(6) - 320-40-03 - 145-deg pe 40mm hum liner +2.5.(b)(6) - 321-52-07 - 3.2mm drill bit sterile.

• Brand Name: SMALL POSTERIOR AUGMENT GLENOID PLATE, 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18278677
• MDR Text Key: 329867653
• Report Number: 1038671-2023-02919
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-35-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2022
• 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
• Treatment: SEE H10.
• Patient Sex: Male