SIG HP FEMORAL TRIALS CASE 950502804

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 2019-10-31 for SIG HP FEMORAL TRIALS CASE 950502804 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

Report Number1818910-2019-113380
MDR Report Key9261158
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-31
Date of Report2019-10-07
Date of Event2019-10-07
Date Mfgr Received2019-11-15
Device Manufacturer Date2008-03-05
Date Added to Maude2019-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIG HP FEMORAL TRIALS CASE
Generic NameKNEE INSTRUMENT : INSTRUMENT CASES
Product CodeFSM
Date Received2019-10-31
Returned To Mfg2019-11-14
Catalog Number950502804
Lot NumberB42AL4
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DR. WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-31

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