MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS GLENOID PLATE SUP AUG, 10 DEG

Model Number 320-15-02

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

Patient Problem Failure of Implant (1924)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the glenoid baseplate.However, this cannot be confirmed because the component was not returned for evaluation.Concomitant device(s): 300-30-10, equinoxe preserve stem 10mm 320-38-00, equinoxe reverse 38mm humeral liner +0 320-10-00, equinoxe reverse tray adapter plate tray +0 320-01-38, equinoxe reverse 38mm glenosphere *no information provided.

Event Description

As reported, approximately 8 months postop the initial right tsa, the patient experienced right aseptic glenoid loosening and was revised.The case report form indicates this event is unlikely related to devices or procedure.This event report was received through clinical data collection activities.The patient has a history of rtc tear and repair, hypertension, and diabetes.Patient was in the hospital for 1 day.Devices will not return to due to study policy.

• Brand Name: EQUINOXE
• Type of Device: RS GLENOID PLATE SUP AUG, 10 DEG
• 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: 11035670
• MDR Text Key: 222268902
• Report Number: 1038671-2020-00653
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-02
• Device Catalogue Number: 320-15-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84