EMPOWR VVC KNEE 346-14-755

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-29 for EMPOWR VVC KNEE 346-14-755 manufactured by Encore Medical L.p..

MAUDE Entry Details

Report Number1644408-2019-01198
MDR Report Key9391959
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-02
Date Mfgr Received2019-11-02
Device Manufacturer Date2019-05-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445
Manufacturer CountryUS
Manufacturer G1ENCORE MEDICAL L.P.
Manufacturer Street9800 METRIC BLVD
Manufacturer CityAUSTIN, TX 78758-5445
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMPOWR VVC KNEE
Generic NameEMPOWR VVC KNEETM TIBIAL INSERT, SIZE 5 BRIDGE UP, 14MM
Product CodeJWH
Date Received2019-11-29
Model Number346-14-755
Catalog Number346-14-755
Lot Number454V1008
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL L.P.
Manufacturer Address9800 METRIC BLVD AUSTIN, TX 78758-5445 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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