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

Model Number 320-15-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-30-06, equinoxe preserve stem 6mm; 320-38-00, equinoxe reverse 38mm humeral liner +0; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-02-38, rs expanded glenosphere 38mm, +4mm offset.

Event Description

As reported, this (b)(6) female patient was diagnosed with a scapular spin stress fracture approximately 14 months postoperatively and has improved with conservative care management.Patient is (b)(6) and has a history of rotator cuff arthropathy, hypertension, and heart disease.The case report form indicates this event is not related to devices but possibly related procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the reported event was a fracture which was likely caused during implantation of the shoulder, however this cannot be confirmed.

• Brand Name: EQUINOXE
• Type of Device: REV GLENOID PLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10859790
• MDR Text Key: 216937821
• Report Number: 1038671-2020-00621
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-01
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 91