Adverse Events Total Hip and Direct Anterior Replacement 2022
Adverse Events Replacement Precautions and Total Hip Replacement 2022
Adverse Events Knee Replacement and Total Hip Replacement 2022
Adverse Events Total Knee Replacement and Total Hip Replacement 2022
Keywords
Direct Anterior
Replacement Precautions
Knee Replacement
Total Knee Replacement
Direct Anterior Knee Replacement
Medical Devices
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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This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2022 through April 29, 2022. 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
2022-04-29
Last Modified
2022-04-29
Version
2022-04-29
Update Frequency
Annual
Temporal Coverage
2022-01-01 to 2022-04-29
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 2022, Adverse Events Replacement Precautions and Total Hip Replacement 2022, Adverse Events Knee Replacement and Total Hip Replacement 2022, Adverse Events Total Knee Replacement and Total Hip Replacement 2022
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: REVISION SURGERY - DUE TO INSTABILITY, EVERYTHING CAME OUT BUT THE SHELL. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Naturally Worn; Appropriate Term/Code Not Available
Insufficient Information
K130365
Event Description: REVISION SURGERY - PATIENT COMPLAINT OF HIP CLICKING. POLY LINER WAS WORN THROUGH AT THE SUPERIOR-POSTERIOR 1/3 MARGIN OF THE LINER. THE CUP WAS ORIGINALLY PLACED IN A VERY VERTICAL POSITION AS INDICATED ON X-RAY. METAL HEAD WAS ALSO REMOVED WITH SOME MINOR SCUFFING OF THE SURFACE. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Adverse Event Without Identified Device or Use Problem
Pain
K120370
Event Description: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND POOR CUP POSITION APPROXIMATELY 2 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. Manufacturer Narrative: (B)(4). CATALOG NUMBER:00-8757-056-01, LOT NUMBER:77010387 BRAND NAME: CONTINUUM TM SHELL. CATALOG NUMBER:00-8852-012-36, LOT NUMBER: 64802356 BRAND NAME: VIT E LINER ELEVATED. CATALOG NUMBER:00-7848-022-00, LOT NUMBER:64746102 BRAND NAME: KINECTIV MODULAR. CATALOG NUMBER:00-6250-065-30, LOT NUMBER:J6793110 BRAND NAME: BONE SCREW. CATALOG NUMBER:00-6250-065-36, LOT NUMBER:J6828155 BRAND NAME: BONE SCREW. CATALOG NUMBER: 00-7713-011-00, LOT NUMBER:64816986 BRAND NAME: M/L TAPER STEM. CATALOG NUMBER: 00-8775-036-02, LOT NUMBER:3043607 BRAND NAME: BIOLOX DELTA HEAD. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT: 0001822565-2022-01023 AND 0001822565-2022-01025. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THEINVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Event Description: IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NV201E - VITELENE INSERT E 32MM SYM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REVISION WAS 6 YEARS POST SURGERY. THE SECOND PROCEDURE WAS PERFORMED BECAUSE THE POLYETHYLENE (PE) INLAY WAS COMPLETELY WORN AWAY. A REVISION SURGERY WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: 400550679 - NV248T - PLASMAFIT PLUS 3 CUP SIZE 48MM E - LOT UNKNOWN; 400550680 - NK562 - BIOLOX PROSTHESIS HEAD 12/14 32MM L - LOT UNKNOWN; 400550681 - NK711T - BICONTACT SD PLASMAPORE 12/14 SIZE 11MM - LOT UNKNOWN. Manufacturer Narrative: MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Event Description: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 1 YEAR POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. Manufacturer Narrative: (B)(4). INITIAL MDR REPORT. SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:EP-200144 LOT NUMBER:926670 BRAND NAME: ACT ARTIC E1 HIP BRG. CATALOG NUMBER:650-1064 LOT NUMBER:2997131 BRAND NAME: CER OPTION TYPE 1 TPR. CATALOG NUMBER:51-102070 LOT NUMBER:6663490 BRAND NAME: TPRLC XR FP TYPE1 PPS. CATALOG NUMBER:110010262 LOT NUMBER:110010262 BRAND NAME: G7 OSSEOTI MULTIHOLE 48MM. CATALOG NUMBER: 110024461 LOT NUMBER:814540 BRAND NAME: G7 DUAL MOBILITY LINER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Event Description: IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO REOCCURRING DISLOCATIONS. THE HEAD AND LINER WERE REVISED AS WELL AS THE CUP TO ADD ANTEVERSION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. Manufacturer Narrative: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 30124006 65003239 G7 VIT E HIGH WALL LNR 40MM F, 802804004 3045483 FEMORAL HEAD TYPE 1 TAPER 40 MM DIAMETER +6 MM NECK LENGTH, 00625006535 J7105893 BONE SCR 6.5X35 SELF-TAP, 00625006535 J6852517 BONE SCR 6.5X35 SELF-TAP, UNKNOWN STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE WAS NOT RELEASED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Event Description: REVISION SURGERY : DUE TO JOINT INSTABILITY. LINER REPLACED WITH NEW DJO LINER. STEM AND HEAD WERE REPLACED WITH IMPLANTS FROM ANOTHER VENDOR. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Event Description: REVISION SURGERY - DUE TO INFECTION. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Event Description: REVISION SURGERY: PATIENT HAD INFECTED HIP.Event Description: REVISION SURGERY: PATIENT HAD INFECTED HIP. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Event Description: REVISION SURGERY DUE TO INFECTION.Event Description: REVISION SURGERY DUE TO INFECTION. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE. Manufacturer Narrative: ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
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