MAUDE Adverse Event Report: EXACTECH, INC. EQ REV GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-15-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/09/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm: 5710508.320-01-42 - equinoxe reverse 42mm glenosphere: 5884751.320-10-00 - equinoxe reverse tray adapter plate tray +0: 5882520.320-15-05 - eq rev locking screw: 5827971.320-20-00 - eq reverse torque defining screw kit: 5884259.320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: 5826540.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 5885855.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 5771283.320-42-00 - equinoxe reverse 42mm humeral liner +0: 5897736.321-20-00 - equinoxe reverse shoulder drill kit: 5029152.

Event Description

As reported by the equinoxe shoulder study, the 63-year-old male patient had an initial right tsa on (b)(6)2019 and presented with acromial fracture/stress fracture, 0 year(s) and 11 month(s) post initial procedure on (b)(6)2020.The outcome of this event is considered unknown and no action was taken.The case report form indicates that this event is possibly 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: EQ REV GLENOID PLATE
• 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: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18763222
• MDR Text Key: 336052058
• Report Number: 1038671-2024-00305
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2018
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White