MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number GLENOSPHERE, 36MM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported a female patient, initial left shoulder implanted on (b)(6) 2024, underwent a revision procedure on (b)(6), 2024.The patient fractured her glenoid.No fall or accident occurred.The surgeon removed the baseplate, hat, reconstructed the glenoid, and implanted a competitor¿s baseplate and exactech tray and liner to match.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for analysis.The surgeon kept them.No further information.

Manufacturer Narrative

D10: concomitants: a699725 - 304-21-09 - 8.5mm platform fx stem left a496893 - 315-35-00 - glnd kwire 6898149 - 320-00-01 - 0 std left tray a791585 - 320-15-05 - eq rev locking screw a592211 - 320-20-00 - eq reverse torque defining screw kit s336580 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s437460 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s375722 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm a746504 - 320-35-02 - small superior augment glenoid plate a589552 - 320-36-00 - 145-deg pe 36mm hum liner +0 a826863 - 531-78-20 - shouldr gps hex pins kit additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18882197
• MDR Text Key: 337409020
• Report Number: 1038671-2024-00461
• Device Sequence Number: 1
• Product Code: PHX
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 02/14/2024
• Date Device Manufactured: 09/21/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Female