MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID SMALL, ALPHA

Model Number 314-13-02

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation: concomitant medical products: 300-30-10, equinoxe preserve stem 10mm; 310-00-47, xs humeral head, 47mm xs offset humeral head; 300-50-45, 4.5mm short rep plate.

Event Description

As reported, this (b)(6) y/o female patient presented with a disassociated of polyethylene component and was revised.Date of initial tsa is unknown.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.The patient was treated as an outpatient and was dismissed home.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to hospital policy.

Manufacturer Narrative

Section h10: (d4) serial number: (b)(6), expiration date: 01-mar-2023 (h3) the revision reported was likely the result of disassociation of the polyethylene component.The cause of the reported disassociation cannot be determined as the devices and x-rays were not available for evaluation and it is unclear if the cage glenoid component disassociated from the glenoid bone or if the cage glenoid¿s metal subcomponents (center cage and/or peripheral pegs) disassociated from the polyethylene body.(h4) device manufacture date: 02-mar-2018.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID SMALL, ALPHA
• 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: 12623244
• MDR Text Key: 276123701
• Report Number: 1038671-2021-00534
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 314-13-02
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White