ANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7 71356107

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-11-27 for ANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7 71356107 manufactured by Smith & Nephew, Inc..

MAUDE Entry Details

Report Number1020279-2019-04173
MDR Report Key9382709
Report SourceCONSUMER,OTHER
Date Received2019-11-27
Date of Report2019-11-27
Date of Event2013-04-22
Date Mfgr Received2019-05-29
Date Added to Maude2019-11-27
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 ContactDR. SARAH FREESTONE
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7
Generic NamePROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Product CodeJDG
Date Received2019-11-27
Catalog Number71356107
Lot Number11FM17364
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-11-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.