MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EXPANDED GLENOSPHERE, 40MM, FOR SMALL REVERSE

Model Number 320-32-40

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): 320-35-01, 7048184 - small glenoid plate; 320-15-05, 7096565 - eq rev locking screw.No information provided in the following section(s).

Event Description

As reported, approximately 2 months post op the initial rtsa, this (b)(6) male patient was revised due to the glenosphere locking screw backing out causing the glenosphere to be loose.The original glenosphere and glenosphere locking screw were explanted and new hardware replaced the effected implants.There was a small surgical delay.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.

Manufacturer Narrative

Section h10: (h3) the screw disassociation reported may have been the result of not properly seating the locking screw which allowed for the screw to back out and led to subsequent loosening of the glenosphere.However, this cannot be confirmed as the devices were not returned for evaluation and x-ray images were not provided.

Manufacturer Narrative

Section h11: *the following sections have corrected information: (h3) the revision reported was likely the result of both allograft being retained on the screw-hole threads of the baseplate and the screw being cross-threaded into the baseplate, which led to incomplete seating of the glenosphere locking screw at the time of implantation.Incomplete seating of the screw likely allowed the screw to back out overtime and caused the glenosphere to become loose on the baseplate.

• Brand Name: EQUINOXE
• Type of Device: EXPANDED GLENOSPHERE, 40MM, FOR SMALL REVERSE
• 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 ; 3523771140
• MDR Report Key: 13060106
• MDR Text Key: 285532489
• Report Number: 1038671-2021-00720
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534989
• UDI-Public: 10885862534989
• 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,Followup,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-32-40
• Device Catalogue Number: 320-32-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male