MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 8.5MM PLATFORM FX STEM RIGHT

Model Number	304-22-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 310-01-47, 6687927 - equinoxe, humeral head short, 47mm (beta); 300-21-00, 6720325 - 0mm fixed angled kit.
Event or Problem Description
As reported, this (b)(6) y/o female patient with no previous medical history, approximately 1 week before suffered a shoulder trauma (humeral head) and was undergoing procedure for repair.Approximately 20 minutes after the procedure began, the patient experienced a tension drop & increase of co2 without any explanation.The surgeon was then inserting suture wires into the tuberosities so that he could fix them after the implantation of the stem.The implant was not yet placed and there was no cement used at this time.There was heart massage with defibrillator.¿patient came back¿ finally so the anatomic fx shoulder has been implanted.At the end of procedure, the patient was transferred to intensive care unit and died afterwards within the day.All available information has been received at this time.It was reported that the implant was not the root cause.
Additional Manufacturer Narrative
(device evaluated by mfr) upon review of this event, it is found not to meet the definition of a complaint, as there is no alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.There is no reasonable causality between the device in the equinoxe shoulder system (304-22-09) to the death of the patient due to a ¿a tension drop & increase of co2 without any explanation just 20 minutes into the procedure¿.The procedure and subsequent death was 1 week after the trauma to the shoulder.It¿s not exactly known how fat emboli and subsequent fes occur, but one leading guess is the ¿mechanical obstruction theory.¿ the idea behind this theory is that when large bones break, fat from the bone marrow, which is made up of fatty cells, seeps into the bloodstream.This fat creates clots (fat emboli) that obstruct blood flow ¿ often in the lungs.These emboli also produce widespread inflammation (1).The patient reported no co-morbidities, other than the previous shoulder (humeral head) trauma, that lend themselves to circulatory emboli, specifically deep vein thrombosis (dvt) or fat embolus.At this time, the most likely cause of the reported event is patient¿s conditions.Out of an abundance of caution, this event is being reported.

• Brand Name: EQUINOXE
• Common Device Name: 8.5MM PLATFORM FX STEM RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11881821
• Report Number: 1038671-2021-00251
• Device Sequence Number: 19811076
• Product Code: KWT
• UDI-Device Identifier: 10885862083395
• UDI-Public: 10885862083395
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 304-22-09
• Device Catalogue Number: 304-22-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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: Death
• Patient Age: 68 YR