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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED, CEMENTED
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EXACTECH, INC. OPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED, CEMENTED Back to Search Results
Catalog Number 02-010-01-0220
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 06/20/2016
Event Type  Injury  
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of aseptic (non-infected) loosening, which damaged the bond of the implant to the bone.
 
Event Description
Index surgery: (b)(6) 2014. Revision of left knee due to aseptic loosening.
 
Event Description
Index surgery:(b)(6) 2014. Revision of left knee due to aseptic loosening.
 
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Brand NameOPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED, CEMENTED
Type of DeviceFEMORAL COMPONENT
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th ct
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th ct
gainesville, FL 32653
MDR Report Key6681253
MDR Text Key110091007
Report Number1038671-2017-00428
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number02-010-01-0220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/30/2017 Patient Sequence Number: 1
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