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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM
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EXACTECH, INC. EQUINOXE; HUMERAL STEM Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.Concomitant devices: replicator plate.Torque screw.Humeral head.Glenoid.
 
Event Description
Primary surgery: (b)(6) 2015.Revision due to infection.The case report form indicates this event is definitely not related to devices and definitely related to procedure.
 
Manufacturer Narrative
The revision reported was likely the result of infection.Any ¿surgical site¿ infection noted in a patient that is greater than 3 months postop from a total joint surgical procedure is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself [1].The reported infection occurred greater than 6 months after the index surgery.Therefore, neither the dhr nor the sterilization records were reviewed.1.Acute infection in total knee arthroplasty: diagnosis and treatment juan carlos martínez-pastor, francisco maculé-beneyto, and santiago suso-vergara.Open orthop j.2013; 7: 197¿204.Published online 2013 jun 14.Superficial or deep infection are listed in the general surgical risks section of the equinoxe shoulder system ifu 700-096-060 rev.M.
 
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Brand Name
EQUINOXE
Type of Device
HUMERAL STEM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8770986
MDR Text Key150381113
Report Number1038671-2019-00365
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight120
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