MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 6.5MM PLATFORM FX STEM LEFT

Model Number	304-23-07
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional 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.Concomitant device(s): 320-36-00, 36mm humeral liner +0 unconstrained 320-10-00, equinoxe reverse tray adapter plate tray +0 320-31-36, glenosphere, 36mm 320-35-01, small glenoid plate.
Event or Problem Description
As reported, during the initial implant of the left tsa, this (b)(6) female patient experienced a humeral fracture, midshaft.Periprosthetic fracture when positioning stem.The case report form indicates this event is not related to devices and possibly related to procedure.This event report was received through clinical data collection activities.Actions taken: long stem and orif of humerus.The patient was discharged after 2 days.Patient has a history of dislocation and breast cancer.

• Brand Name: EQUINOXE
• Common Device Name: 6.5MM PLATFORM FX STEM LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11514985
• Report Number: 1038671-2021-00119
• Device Sequence Number: 11713531
• Product Code: KWT
• UDI-Device Identifier: 10885862083425
• UDI-Public: 10885862083425
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: 304-23-07
• Device Catalogue Number: 304-23-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80