MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV GLENOID PLATE

Model Number 320-15-01

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: pending evaluation.Concomitant device(s): 300-01-15, 6332321 - equinoxe, humeral stem primary, press fit 15mm.320-20-00, 6519700 - eq reverse torque defining screw kit.320-15-05, 6490907 - eq rev locking screw.320-10-00, 6474248 - equinoxe reverse tray adapter plate tray +0.320-01-36, 6310869 - 36mm glenosphere.

Event Description

Approximately 16 mos postop the initial right tsa, the (b)(6) female patient had glenoid notching.When investigating, the surgeon found the glenoid baseplate was loose.Patient was revised to a hemiarthroplasty and is awaiting bone graft take-up of the glenoid.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of an insufficient bond between the glenoid baseplate and the bone and/or patient-related conditions, which led to aseptic (non-infected) glenoid baseplate loosening.However, this cannot be confirmed as the devices and x-rays were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: EQ REV GLENOID PLATE
• 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: 13003434
• MDR Text Key: 286731622
• Report Number: 1038671-2021-00694
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-01
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female