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Adverse Event Report

EXACTECH, INC. CR CEMENTED FEMORAL COMPONENT   back to search results
Catalog Number 200-01-03
Event Date 08/06/2002
Event Type  Other   Patient Outcome  Other;
Event Description

Patient required revision of total knee arthroplasty because of chronic pain. All components removed and replaced.

 
Manufacturer Narrative

Knee components involved in revision procedure are not available for evaluation.

 
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Brand NameCR CEMENTED FEMORAL COMPONENT
Type of DeviceFEMORAL COMPONENT
Baseline Brand NameCR CEMENTED FEMORAL COMPONENT
Baseline Generic NameFEMORAL COMPONENT
Baseline Catalogue Number200-01-03
Baseline Device FamilyOPTETRAK
Baseline Device 510(K) NumberK932690
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed02/09/1995
Manufacturer (Section F)
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville FL 32653
Manufacturer (Section D)
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville FL 32653
Manufacturer Contact
susan horne
2320 nw 66th court
gainesville , FL 32653
(352) 377 -1140
Device Event Key404851
MDR Report Key415810
Event Key393212
Report Number1038671-2002-00016
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 09/12/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number200-01-03
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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