COCR FEM 12/14 FEM HD 28 + 8 71302808

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 COCR FEM 12/14 FEM HD 28 + 8 71302808 manufactured by Smith & Nephew, Inc..

Event Text Entries

[185723976] It was reported that a revision surgery was performed due to femoral neck fracture. Stem and femoral head were explanted and replaced for zimmer biomet stem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2020-01085
MDR Report Key9902611
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-04
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 ContactDR. SARAH FREESTONE
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone0447940038
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 NameCOCR FEM 12/14 FEM HD 28 + 8
Generic NamePRSTHSISHIPSMICNSTRINDMTALPLYMRPROUSUNCMNTD
Product CodeLPH
Date Received2020-03-31
Model Number71302808
Catalog Number71302808
Lot Number05CM15472
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2020-03-31

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