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Adverse Event Report

EXACTECH, INC. CR CEMENTED 3 PEG PATELLA (DEVICE #3)   back to search results
Catalog Number 200-02-35
Event Date 04/26/2004
Event Type  Other   Patient Outcome  Hospitalization; Other
Event Description

Hosp reported a total knee arthroplasty revision due to "gradually increasing pain in the knee, especially with activities. During the procedure, the surgeon discovered the femoral component to hang over on the medial side and tibia overhanging on the lateral side. " no device defect associated with the revision was reported.

 
Manufacturer Narrative

Component was not available for eval. A review of the mfg dhr found no discrepancies.

 
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Brand NameCR CEMENTED 3 PEG PATELLA (DEVICE #3)
Type of DevicePATELLA
Baseline Brand NameCR CEMENTED THREE PEG PATELLA
Baseline Generic NamePATELLA COMPONENT
Baseline Catalogue Number200-02-35
Baseline Device FamilyCRUCIATE RETAINING CEMENTED COMPONENTS
Baseline Device 510(K) NumberK932690
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed02/09/1995
Manufacturer (Section F)
EXACTECH, INC.
2302 n.w. 66th ct.
gainesville FL 32653
Manufacturer (Section D)
EXACTECH, INC.
2302 n.w. 66th ct.
gainesville FL 32653
Manufacturer Contact
susan horne
2320 nw 66th court
gainesville , FL 32653
(352) 377 -1140
Device Event Key529674
MDR Report Key540365
Event Key513091
Report Number1038671-2004-00037
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number200-02-35
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/29/2004
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
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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