Medical Device Adverse Events for Total Hip Replacements

**Overview**
This accelerator contains report on Adverse Events Total Hip Replacement for year 2014, 2015 and 2016.

**Description**
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 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 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.
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.

**Benefits**
- Useful for physicians for hip replacement which includes: hip replacement reports,
- medical device reports (mdr),
- mdrs submitted by the fda,
- death reports to fda, serious injuries reports to fda, manufacturer and user facility device experience, knee replacement.

**License Information**
The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the [Data Library](https://www.johnsnowlabs.com/marketplace/) on John Snow Labs website. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

**Included Datasets**
- [Adverse Events Total Hip Replacement 2014](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2015](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2016](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2017](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2018](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2019](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2020](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2021](https://www.johnsnowlabs.com/marketplace/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.
- [Adverse Events Total Hip Replacement 2022](https://www.johnsnowlabs.com/marketplace/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.

**Data Engineering Overview**
**We deliver high-quality data**
- Each dataset goes through 3 levels of quality review
- 2 Manual reviews are done by domain experts
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- Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

**Our data is curated and enriched by domain experts**

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:
- Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
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