MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE, 36MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOSPHERE, 36MM

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/13/2020

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2020.The patient presented on (b)(6) 2020 and had acromial fracture type 1.The case report form indicates that this event is possibly related to device, possibly related to procedure.Outcome: resolved on (b)(6)2021.

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), 320-35-01 - small glenoid plate.

• Brand Name: GLENOSPHERE, 36MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17850223
• MDR Text Key: 324661060
• Report Number: 1038671-2023-02406
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White