MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID MEDIUM, BETA

Model Number 314-13-13

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

The center cage disassociation reported may have been the result of the device being impacted off-axis, the center cage becoming deformed during insertion, the surgeon being unaccustomed to implanting caged glenoids, or a combination of the three, which allowed the center cage to disassociate from the polyethylene body.However, this cannot be confirmed as the device was not available for evaluation.

Event Description

As reported, this was the surgeon first experience with the caged glenoid and primary joint replacement for this (b)(6) y/o male patient.Upon insertion, the center cage disassociated from the poly.Time delay due to removal of cement from peripheral pegs and mixing of 2nd cement to implant all poly glenoid.The surgeon implanted an all poly glenoid, medium beta.There was a 5-15-minute delay in the procedure due to removal of cement from peripheral pegs and mixing of 2nd cement to implant all poly glenoid.The patient was last known to be in stable condition following the event.The device was disposed of by the facility.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID MEDIUM, BETA
• 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
• MDR Report Key: 11165732
• MDR Text Key: 227519838
• Report Number: 1038671-2021-00008
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Model Number: 314-13-13
• Device Catalogue Number: 314-13-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2017
• Is the Device Single Use?: No
• 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: 40 YR