Adverse Events Total Hip Replacement 2018

$447.50 / year

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2018 through December 31, 2018.

Complexity

This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2018 through December 31, 2018. 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.

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The Manufacturer and User Facility Device Experience Database (MAUDE) database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

Date Created

2018-01-01

Last Modified

2018-12-31

Version

2018-12-31

Update Frequency

Annual

Temporal Coverage

2018-01-01 to 2018-12-31

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 2018, Adverse Events Replacement Precautions and Total Hip Replacement 2018, Adverse Events Knee Replacement and Total Hip Replacement 2018, Adverse Events Total Knee Replacement and Total Hip Replacement 2018

NameDescriptionTypeConstraints
Web_AddressWebsite link to adverse event reportstring-
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=8202415&pc=HBE1030489-2018-017092018-11-30InjuryMEDTRONIC SOFAMOR DANEK USA, INC2018-12-28HBEPOWEREASE INSTRUMENTS IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION PROCEDURE. DURING THE SURGERY, THE SCREW DRIVER TIP BROKE OFF IN THE SCREW WHEN THE SCREW WAS ADVANCED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8203218&pc=HBE1045254-2018-00745InjuryMEDTRONIC XOMED INC.2018-12-28HBE A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE FOOT PEDAL MALFUNCTIONED AND CAUSED PATIENT HARM DURING THE PROCEDURE. THE HCP ALSO NOTED THAT THE PERFORATOR KEPT SPINNING WITH NO PRESSURE ON THE FOOT PEDAL. Manufacturer Narrative: SUBMITTING THIS REGULATORY REPORT IN REFERENCE TO MEDWATCH FORM #: 1625507-2018-00080. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8203621&pc=HBE1045254-2018-007482018-12-02MalfunctionMEDTRONIC XOMED INC.2018-12-28HBE A REGULATORY BODY REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HEAD OF THE DEVICE WAS BROKEN WHEN THE BOX WAS OPENED PRIOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. Manufacturer Narrative: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8190078&pc=HBE1045834-2018-525072018-11-08MalfunctionDEPUY SYNTHES PRODUCTS LLC2018-12-21HBE4MM COARSE DIAMOND BALL, 15 CM IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE CUTTER DEVICE WAS STUCK INSIDE THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT A PIECE OF THE CUTTER DEVICE WAS BROKEN OFF AND STUCK INSIDE THE ATTACHMENT DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. Manufacturer Narrative: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. QUALITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ATTACHMENT DEVICE WAS TAKEN APART AND IT WAS NOTED THAT EXCESSIVE FORCE WAS APPLIED, AND MEDICAL DEBRIS WAS OBSERVED IN THE LOCKING MECHANISM ASSEMBLY WHICH PREVENTED THE LOCK TABS FROM RELEASING THE CUTTER DEVICE WHICH IN TURN, CAUSED THE FAILURE. THE PIECE OF THE CUTTER DEVICE WAS EXAMINED USING 25X MAGNIFICATION AND RECHECKED ON AN OPTICAL COMPARATOR. A FULL ASSESSMENT OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE CONDITION OF WHICH THE CUTTER DEVICE WAS RECEIVED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191104&pc=HBE1045834-2018-524992018-12-01InjuryDEPUY SYNTHES PRODUCTS LLC2018-12-21HBECOMPACT SPEED REDUCER, 60:1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191123&pc=HBE1045834-2018-525022018-11-27InjuryDEPUY SYNTHES PRODUCTS LLC2018-12-21HBECOMPACT SPEED REDUCER, 60:1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191298&pc=HBE1045834-2018-525042018-11-30InjuryDEPUY SYNTHES PRODUCTS LLC2018-12-21HBECOMPACT SPEED REDUCER, 60:1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191341&pc=HBE1045834-2018-525062018-12-07InjuryDEPUY SYNTHES PRODUCTS LLC2018-12-21HBECOMPACT SPEED REDUCER, 60:1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191389&pc=HBE1045834-2018-525092018-06-07InjuryDEPUY SYNTHES PRODUCTS LLC2018-12-21HBECOMPACT SPEED REDUCER, 60:1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=8191489&pc=HBE1045834-2018-525112018-10-23InjuryDEPUY SYNTHES PRODUCTS LLC2018-12-21HBECOMPACT SPEED REDUCER, 60:1