Adverse Events Total Hip Replacement 2016

$447.50 / year

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2016 through December 31, 2016.

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 01, 2016 through December 31, 2016. The reports are submitted to the FDA by both mandatory and voluntary reporters. Mandatory reports are provided by manufactures, 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

2016-01-01

Last Modified

2016-12-31

Version

2016-12-31

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 2016, Adverse Events Replacement Precautions and Total Hip Replacement 2016, Adverse Events Knee Replacement and Total Hip Replacement 2016, Adverse Events Total Knee Replacement and Total Hip Replacement 2016

NameDescriptionTypeConstraints
Web_AddressWebsite link to adverse event reportstringrequired : 1
Report_NumberAdverse event report numberstring-
Event_DateDate the event occurreddate-
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
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6085172&pc=HWC60851722016-10-27MalfunctionSMITH & NEPHEW, INC.2016-11-08HWCTRIGEN BROKEN SCREW REMOVED. Manufacturer Narrative: .
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6116316&pc=NXTMW5066195MalfunctionSMITH AND NEPHEW2016-11-17NXTBIRMINGHAN HIP RESURFACING DEVICE CAUSED EXTENSIVE OSTEOLYSIS OF BONE.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6026869&pc=LWJ3010536692-2016-011522016-06-13InjuryMICROPORT ORTHOPEDICS INC.2016-10-13LWJPROFEMUR(R) MODULAR FEMORAL NECK ALLEGEDLY, BROKEN NECK.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6056919&pc=NBH60569192016-09-01MalfunctionARTHREX, INC.2016-10-26NBHMULTIFIRE SCORPION NEEDLE TIP BROKE OFF DURING SURGERY. Manufacturer Narrative: .
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6064244&pc=GCJ3005075853-2016-061622016-06-27MalfunctionETHICON ENDO-SURGERY, LLC.2016-10-28GCJENDOPOUCH SPECIMEN RETRIEVER . Manufacturer Narrative: (B)(4).
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=5357316&pc=JDO2530191-2016-000082015-12-11MalfunctionSTELKAST INC.2016-01-11JDOPROFORM HIP SYSTEM ACETABULAR BONE SCREW BENT WHEN IMPLANTING ACETABULAR SHELL.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=5466163&pc=NBH54661632016-02-22InjuryARTHREX INC.2016-02-29NBHSUREFIRE SCORPION NEEDLE TIP OF SCORPION NEEDLE BROKE DURING PROCEDURE. Manufacturer Narrative: .
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=5897614&pc=JDL3010536692-2016-01099InjuryMICROPORT ORTHOPEDICS INC.2016-08-23JDLLINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD ALLEGEDLY, LEFT INFECTED HIP.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6155927&pc=KWZ0001822565-2016-045842016-11-14InjuryZIMMER, INC.2016-12-08KWZUNKNOWN ZIMMER HIP IT IS REPORTED THAT A PATIENT WAS REVISED DUE TO UNKNOWN REASONS.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=5403994&pc=MAY2530191-2016-000302015-12-30NASTELKAST INC.2016-02-02MAYEXP ACETABULAR SHELL AND LINER PATIENT PRESENTED FOR REVISION SURGERY FOR A LOOSE HIP LINER.