Adverse Events Total Hip and Direct Anterior Replacement 2020
Adverse Events Replacement Precautions and Total Hip Replacement 2020
Adverse Events Knee Replacement and Total Hip Replacement 2020
Adverse Events Total Knee Replacement and Total Hip Replacement 2020
Keywords
Direct Anterior
Replacement Precautions
Knee Replacement
Total Knee Replacement
Direct Anterior Knee Replacement
Medical Devices
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.
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This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2020 through December 31, 2020. 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
2020-01-01 to 2020-12-31
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 2020, Adverse Events Replacement Precautions and Total Hip Replacement 2020, Adverse Events Knee Replacement and Total Hip Replacement 2020, Adverse Events Total Knee Replacement and Total Hip Replacement 2020
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)
Event Description: IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: DATE OF EVENT: USED (B)(6) 2019 AS THE CORRECT DATE WAS NOT PROVIDED.
Event Description: IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 10.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING INFLATION, THE PRESSURE DID NOT INCREASE AND UPON CHECKING THE BALLOON, A HOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. Manufacturer Narrative: (B)(6).
Event Description: IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INITIALLY INFLATED AT 12 ATMOSPHERES; HOWEVER, DURING THE SECOND INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Event Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL ANTERIOR FIXATION AT C6/7 DUE TO CERVICAL SPINE TRAUMA. POST-OP, THE SCREWS WERE INTEGRATED WITH TWO PLATES AND IT SEEMED THAT THE LOWER PART OF THE PLATE HAS COME OF RATHER THAN THE SCREW CAME OFF AND HAS BEEN A LITTLE UNSTABLE. THERE WAS AN IMPRESSION THAT INTRA-OPERATIVE, BONE QUALITY WAS QUITE BAD. HENCE ON (B)(6) 2019, FIXATION WAS PERFORMED FROM THE POSTERIOR SIDE(VS WAS USED AT C4/5/6, T1/2/3) BUT REMOVAL HAD NOT BEEN PERFORMED. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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.
Event Description: IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A NEW RV LEAD DUE TO LEAD FRACTURE. HIGH, OUT OF RANGE PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD WERE OBSERVED. THE LEAD WAS CAPPED AND REPLACED ON (B)(6)2019. THE PATIENT WAS STABLE. Manufacturer Narrative: THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Event Description: IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE ON (B)(6) 2019, HIGH THRESHOLDS WERE OBSERVED IN ANY POSITION. THE PHYSICIAN TRIED SEVERAL TIMES TO REPLACE THE LEAD ON OTHER POSITION BUT STILL FAILED. THE PHYSICIAN USED ANOTHER LEAD TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED ON THE PATIENT. Manufacturer Narrative: THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL. Manufacturer Narrative: THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Event Description: IT WAS REPORTED BY AN EYE CARE PROFESSIONAL (ECP) THAT A PATIENT WAS SEEN ON (B)(6) 2019 FOR A ROUTINE EYE EXAMINATION AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF VISIT. THE PATIENT WAS SEEN BY AN OPHTHALMOLOGIST FOLLOWING THE ROUTINE EYE EXAMINATION AND WAS DIAGNOSED WITH AN EYE INFECTION. THE DATE OF MEDICAL INTERVENTION AS WELL AS EYE INVOLVED WAS UNKNOWN. THE PATIENT WAS THEN REFERRED TO A HEALTHCARE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 VIA A TELEPHONE CALL FROM THE OFFICE OF THE ECP. IT WAS REPORTED THAT THE PATIENT VISITED ON (B)(6) 2019 AFTER CONTACT LENS FITTING ON (B)(6) 2019. IT WAS NOTED THAT THE PATIENT WAS A COMPETITIVE SWIMMER. THE PATIENT WOKE UP IN PAIN AND CHANGED OUT THE ORIGINAL CONTACT LENS. THE PATIENT PLACED THE SECOND LENS IN HIS EYE AND CONTINUED TO HAVE PAIN WHICH QUICKLY PROGRESSED. THE PATIENT WAS THEN REFERRED TO A HEALTHCARE FACILITY. ON (B)(6) 2019, IT WAS MENTIONED THAT THE PATIENT WAS GETTING BETTER. ON (B)(6) 2019, THE PATIENT WAS DIAGNOSED WITH ULCER OF THE RIGHT EYE (OD) AND WAS PRESCRIBED WITH MOXIFLOXACIN, TREATMENT MODALITY UNKNOWN. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP VISIT ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. Manufacturer Narrative: THIS IS THE FIRST OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO LOT NUMBERS OF THE SAME PRODUCT. IT IS UNKNOWN WHICH CONTRIBUTED TO THE EVENT. REFER TO (B)(4) FOR THE REPORTED LOT NUMBER 31369413. THERE IS NO RETURN SAMPLE RECEIVED FROM COMPLAINANT DURING THE REPORT IS BEING MADE, THEREFORE NO PRODUCT EVALUATION CAN BE PERFORMED. AS NO PRODUCT HAS BEEN RETURNED, THE INVESTIGATION WAS SOLELY BASED ON A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 31369413. THE MANUFACTURING INVESTIGATION THROUGH DEVICE HISTORY RECORD REVIEW OF LOT 31369413 HAS BEEN CONDUCTED. THIS LOT HAS GONE THROUGH ALL MANUFACTURING PROCESS STAGES AS REQUIRED BY THE PROCEDURES. THERE WAS NO NONCONFORMITY RELATED TO THE NATURE OF COMPLAINT OCCURRED DURING THE MANUFACTURING PROCESS. ALL IN-PROCESS INSPECTION RECORDS AND FINAL PRODUCT INSPECTION RECORD CONFIRMED TO BE WITHIN SPECIFICATIONS. THE DRY LENS FA # (B)(4) WAS ASSIGNED TO LOT 31369413 AND CONFIRMED MET THE MOLDING PROCESS SPECIFICATIONS. THIS LOT HAS GONE THROUGH 100% WET VISUAL COSMETIC INSPECTION FOLLOWING STANDARD OPERATING PROCEDURES. THE AQL SAMPLING TAKEN FOR VISUAL COSMETIC QUALITY AT QC ONLINE PRIMARY PACKAGING INSPECTION, QC MANTIS SAMPLING INSPECTION AND FINAL COSMETIC SAMPLING INSPECTION AT QC PAI WERE CONFIRMED TO MEET THE ACCEPTANCE CRITERIA. THE LOT 31369413 WAS PROCESSED AT PRIMARY PACKAGING MACHINE # (B)(4). THE SAMPLING TAKEN FOR PACKAGE INTEGRITY DURING PRIMARY PACKAGING PROCESS, QC MANTIS SAMPLING INSPECTION, AND QC POST AUTOCLAVE INSPECTION WERE WITHIN THE SPECIFICATIONS. THE BATCH RECORD OF SALINE PACKAGING SOLUTION # (B)(4) THAT USED FOR THIS LOT HAS BEEN REVIEWED AND MET THE SPECIFICATION. THE STERILIZATION PROCESS PARAMETER AND BI INCUBATION RESULT ALSO MET SPECIFICATIONS. INFECTIOUS CORNEAL ULCER IS OFTEN REFERRED TO AS ¿MICROBIAL KERATITIS¿ OR ¿INFECTIOUS KERATITIS¿. THIS CASE CAUSES BY A MICROBIAL AGENT I.E. BACTERIAL, VIRAL, FUNGAL, OR AMOEBA. THE MANUFACTURING SITE HAS INSPECTED THE PRODUCT RETAIN SAMPLES OF LOT 31369413 TO ENSURE WHETHER THERE IS ANY POSSIBILITY OF PRODUCT CONTAMINATION, THEREFORE PACKAGE INTEGRITY INSPECTION OF RETAIN SAMPLES WAS PERFORMED BY VISUALLY INSPECTION AND VACUUM TESTING TO ENSURE THERE ARE NO LEAKS OR OTHER PACKAGE INTEGRITY DEFECTS THAT COULD LEAD TO CONTAMINATE PRODUCT. 12 RETAIN SAMPLES INSPECTED SHOWED TO MEET SPECIFICATIONS, NO PACKAGE INTEGRITY DEFECT FOUND. THE COMPLAINT DATA AND TREND RELATED TO ¿H-INFECTION - NOT OTHERWISE SPECIFIED (MODERATE); H-EYE PAIN; H-CORNEAL ULCER INFECTIOUS¿ FOR LOTRAFILCON A PRODUCT HAS BEEN REVIEWED AND DID NOT INDICATE ANY ADVERSE TREND, OVERALL DATA METRICS ARE WITHIN THE CONTROL LIMIT. TRACKING IN COMPLAINT DATABASE, THERE WAS NO OTHER SIMILAR COMPLAINT REPORTED TO THIS LOT. BASED ON THE INVESTIGATION, THIS LOT HAS PASSED THROUGH ALL MANUFACTURING PROCESS AS REQUIRED BY THE PROCEDURES. THE LOT WAS CONFIRMED TO MEET ALL IN-PROCESS AND FINISHED PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE. THIS COMPLAINT CAN BE CONSIDERED AS AN ISOLATED CASE AS THERE IS NO OTHER SIMILAR COMPLAINT REPORTED TO THIS LOT. NO ROOT CAUSE CAN BE DETERMINED. THERE IS NO IMPACT TO THE OTHER PRODUCT AND NO FIELD ACTION ASSESSMENT (FAA) IS REQUIRED. NO CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) WILL BE INITIATED FOR THIS COMPLAINT. CONTINUOUS MONITORING OF THESE TYPES OF EVENTS THROUGH TRENDING AND ANALYSIS MAY INDICATE FUTURE ACTION. (B)(4).
Event Description: IT WAS REPORTED THAT HIGH ATRIAL CAPTURE THRESHOLD WAS OBSERVED. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS DISCHARGED. Manufacturer Narrative: THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Event Description: IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.00X20MM PROMUS ELEMENT DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. Manufacturer Narrative: DEVICE IS A COMBINATION PRODUCT.
Demos
