FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT N/A 00588001401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT N/A 00588001401 manufactured by Zimmer Biomet, Inc..

MAUDE Entry Details

Report Number0001822565-2020-01203
MDR Report Key9908158
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-11
Date Mfgr Received2020-03-16
Device Manufacturer Date2017-07-14
Date Added to Maude2020-03-31
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameFEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT
Generic NamePROSTHESIS, KNEE
Product CodeJWH
Date Received2020-03-31
Model NumberN/A
Catalog Number00588001401
Lot Number63614821
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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