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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; THREE PEG PATELLA 38MM

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EXACTECH, INC. OPTETRAK; THREE PEG PATELLA 38MM Back to Search Results
Catalog Number 200-02-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Date 02/15/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2015.Revision due to sepsis of a total knee arthroplasty.The case report form indicates this event is possibly related to devices and procedure.
 
Manufacturer Narrative
This event report was received through clinical data collection activities.Engineering evaluation noted that the revision reported was likely the result of infection, which is addressed in the product labeling under general surgical risks.
 
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Brand Name
OPTETRAK
Type of Device
THREE PEG PATELLA 38MM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8206153
MDR Text Key131712890
Report Number1038671-2018-00985
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/14/2019
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 Catalogue Number200-02-38
Was Device Available for Evaluation? No
Distributor Facility Aware Date12/02/2018
Initial Date Manufacturer Received 12/02/2018
Initial Date FDA Received12/31/2018
Supplement Dates Manufacturer Received12/02/2018
Supplement Dates FDA Received01/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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