Others titles
- Adverse Events Total Hip and Direct Anterior Replacement 2019
- Adverse Events Replacement Precautions and Total Hip Replacement 2019
- Adverse Events Knee Replacement and Total Hip Replacement 2019
- Adverse Events Total Knee Replacement and Total Hip Replacement 2019
Keywords
- Direct Anterior
- Replacement Precautions
- Knee Replacement
- Total Knee Replacement
- Direct Anterior Knee Replacement
- Medical Devices
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.
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Description
This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2019 through December 31, 2019. 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.
About this Dataset
Data Info
Date Created | 2021-04-18 |
---|---|
Last Modified | 2021-04-21 |
Version | 2021-03-31 |
Update Frequency |
Annual |
Temporal Coverage |
2019-01-01 to 2019-12-31 |
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 2019, Adverse Events Replacement Precautions and Total Hip Replacement 2019, Adverse Events Knee Replacement and Total Hip Replacement 2019, Adverse Events Total Knee Replacement and Total Hip Replacement 2019 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Web_Address | Website link to adverse event report | string | - |
Report_Number | Adverse event report number | string | - |
Event_Date | Date the event occurred | date | - |
Event_Type | Type of event: Injury, Malfunction, or Death | string | - |
Manufacturer | Manufacturer of the device that caused the adverse event | string | - |
Date_Received | Date the adverse event report was received by the Food and Drug Administration | date | - |
Product_Code | Classification product code used by the Food and Drug Administration | string | - |
Brand_Name | Market name of the device | string | - |
Device_Problem | Indicate the problem with the device | string | - |
Patient_Problem | Type String | - | |
PMA_PMN_Number | Premarket approval (PMA) & Premanufacture number (PMN) | string | - |
Event_Description | Narrative of the adverse event | string | - |
Data Preview
Web Address | Report Number | Event Date | Event Type | Manufacturer | Date Received | Product Code | Brand Name | Device Problem | Patient Problem | PMA PMN Number | Event Description |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536684&pc=DZE | 0009613348-2019-56746 | 2019-10-09 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BLT Ã3.3MM NC, SLA® 10MM, TIZR, LOXIM | Failure to Osseointegrate | Pain; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 21. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION PER FDA LETTER DATED JUNE 28, 2019. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536685&pc=QBJ | 3004753838-2019-114251 | 2019-12-23 | Malfunction | DEXCOM, INC. | 2019-12-31 | QBJ | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | No Device Output | No Consequences Or Impact To Patient | DEN170088 | Event Description: IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.Event Description: THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND PASSED. A PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A TRANSMITTER FAILED ERROR WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. Manufacturer Narrative: (B)(4). Manufacturer Narrative: (B)(4). |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536686&pc=DZE | 0009613348-2019-56751 | 2019-10-09 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BL, à 3.3MM NC, SLA® 12MM, TIZR, NTP | Failure to Osseointegrate | Pain; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 31. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION PER FDA LETTER DATED JUNE 28, 2019. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536687&pc=DZE | 0009613348-2019-56761 | 2019-10-13 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BLT Ã3.3MM NC, SLA® 14MM, TIZR, LOXIM | Failure to Osseointegrate | Pain; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 24. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION PER FDA LETTER DATED JUNE 28, 2019. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536688&pc=DZE | 0009613348-2019-56748 | 2019-10-09 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | SP à 3.3MM RN, SLA® 10MM, TIZR, NTP | Failure to Osseointegrate | Pain; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 12. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION PER FDA LETTER DATED JUNE 28, 2019. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536689&pc=DZE | 0009613348-2019-56843 | 2019-12-05 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | CI Ã4.1MM RD, ZLA 14MM, ZRO2 | Failure to Osseointegrate | Tissue Damage | K180477 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 30. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536690&pc=DZE | 0009613348-2019-56753 | 2019-11-10 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BLT Ã4.1MM RC, SLA® 8MM, TIZR, LOXIM | Failure to Osseointegrate | Pain; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 34. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION PER FDA LETTER DATED JUNE 28, 2019. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536691&pc=DZE | 0009613348-2019-56852 | 2019-12-04 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BLT Ã4.1MM RC, SLA® 10MM, TIZR, LOXIM | Failure to Osseointegrate | Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 20. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536692&pc=DZE | 0009613348-2019-56757 | 2019-10-12 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BLT Ã3.3MM NC, SLA® 10MM, TIZR, LOXIM | Failure to Osseointegrate | Pain; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 12. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: REPORT LATE DUE TO ASR TO INDIVIDUAL REPORTING TRANSITION PER FDA LETTER DATED JUNE 28, 2019. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=9536693&pc=DZE | 0009613348-2019-56817 | 2019-12-03 | Injury | INSTITUT STRAUMANN AG | 2019-12-31 | DZE | BLT Ã4.1MM RC, SLA® 10MM, TIZR, LOXIM | Failure to Osseointegrate | Unspecified Infection; Tissue Damage | K150938 | Event Description: THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 24. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. |