Medical Device Adverse Events for Total Hip Replacements

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 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about the frequency of device use. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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.

Manufacturers and importers submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Manufacturers must send reports of such deaths, serious injuries and malfunctions to the FDA. Importers must send reports of deaths and serious injuries to the FDA and the manufacturer, and reports of malfunctions to the manufacturer.

Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when they become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury of a patient in their facility. Death reports must be sent to the FDA and the manufacturer, if known. Serious injury reports must be sent to the manufacturer or to the FDA if the manufacturer is not known.

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1. Adverse Events Total Hip Replacement 2014

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 2014 through December 2014.

2. Adverse Events Total Hip Replacement 2015

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

3. Adverse Events Total Hip Replacement 2016

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.

4. Adverse Events Total Hip Replacement 2017

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2017 through December 31, 2017.

5. Adverse Events Total Hip Replacement 2018

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.

6. Adverse Events Total Hip Replacement 2019

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2019 through December 31, 2019.

7. Adverse Events Total Hip Replacement 2020

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2020 through December 31, 2020.

8. Adverse Events Total Hip Replacement 2021

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2021 through December 31, 2021.

9. Adverse Events Total Hip Replacement 2022

This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2022 through April 29, 2022.

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John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.