MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM GLENOSPHERE

Model Number 320-01-38

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

Patient Problem Failure of Implant (1924)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; 320-38-00 - equinoxe reverse 38mm humeral liner +0; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-15-02 - rs glenoid plate sup aug, 10 deg.

Event Description

As reported, approximately 2 years post op initial left tsa, this (b)(6) female patient started experiencing aseptic glenoid loosening.Revision for study has not yet occurred, no action was taken at this time.The case report form indicates this event is possibly related to devices and procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

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

• Brand Name: EQUINOXE
• Type of Device: REVERSE 38MM GLENOSPHERE
• 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: 13060324
• MDR Text Key: 282629371
• Report Number: 1038671-2021-00724
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White