Adverse Events Total Hip Replacement 2015

$447.50 / year

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 2015 through December 2015.

Complexity

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 2015 through December 2015. The reports are submitted to the FDA by both mandatory and voluntary reporters. Mandatory reports are provided by manufacturers, importers, and device user facilities, such as hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Voluntary reports are provided by health care professionals, patients and consumers. The reports include suspected device-associated deaths, serious injuries and malfunctions. The FDA uses the reports to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of the products.

Date Created

2015-01-01

Last Modified

2016-01-06

Version

2016-01-06

Update Frequency

Annual

Temporal Coverage

2014-01-01 to 2014-12-31

Spatial Coverage

United States

Source

John Snow Labs; United States Food and Drug Administration;

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Direct Anterior, Replacement Precautions, Knee Replacement, Total Knee Replacement, Direct Anterior Knee Replacement, Medical Devices

Other Titles

Adverse Events Total Hip and Direct Anterior Replacement 2015, Adverse Events Replacement Precautions and Total Hip Replacement 2015, Adverse Events Knee Replacement and Total Hip Replacement 2015, Adverse Events Total Knee Replacement and Total Hip Replacement 2015

NameDescriptionTypeConstraints
Web_AddressWebsite link to adverse event reportstringrequired : 1
Report_NumberAdverse event report numberstring-
Event_DateDate the event occurredstring-
Event_TypeType of event: Injury, Malfunction, or Deathstring-
ManufacturerManufacturer of the device that caused the adverse eventstring-
Date_ReceivedDate the adverse event report was received by the Food and Drug Administrationdate-
Product_CodeClassification product code used by the Food and Drug Administrationstring-
Brand_NameMarket name of the devicestring-
Event_DescriptionNarrative of the adverse eventstring-
Web_AddressReport_NumberEvent_DateEvent_TypeManufacturerDate_ReceivedProduct_CodeBrand_NameEvent_Description
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=473256047325602015-04-03MalfunctionBIOMET2015-04-09KWYREGENEREX RINGLOC
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=481099548109952015-04-10MalfunctionDEPUY ORTHOPAEDICS, INC.2015-05-27LPHPINNACLE
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=5076879&pc=MAX1030489-2015-02357InjuryMEDTRONIC SOFAMOR DANEK2015-09-15MAXCLYDESDALE SPINAL SYSTEM
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=5076855&pc=MAX1030489-2015-02355InjuryMEDTRONIC SOFAMOR DANEK2015-09-15MAXCLYDESDALE SPINAL SYSTEM
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=50780901818910-2015-306112015-02-25InjuryDEPUY FRANCE SAS - 300389557552015-09-15KXACORAIL2 STD SIZE 11
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=50790711818910-2015-305452015-09-10InjuryDEPUY IRELAND REG. # 96166712015-09-15LZODELTA CER HEAD 12/14 32MM +5
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=484004748400472015-05-04MalfunctionJOHNSON & JOHNSON2015-06-04LWJDEPUY ARS EXPLANT OF DEPUY ASR LEFT HIP IMPLANT.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=50771831818910-2015-305552014-05-07InjuryDEPUY ORTHOPAEDICS, INC. - 18189102015-09-15JDGSUMMIT POR TAPER SZ4 HI OFF
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=50776441818910-2015-305752014-06-12InjuryDEPUY ORTHOPAEDICS, INC. - 18189102015-09-15KXASUMMIT POR TAPER SZ6 HI OFF
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=50780751818910-2015-306072015-02-25InjuryDEPUY INTERNATIONAL LTD - 80103792015-09-15KWYDEPUY ASR XL FEM IMP SIZE 41