Others 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
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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Description
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) | 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=14188549&pc=OQG | 1644408-2022-00525 | 2022-04-05 | Injury | ENCORE MEDICAL L.P | 2022-04-22 | OQG | X-ALT HIP | Appropriate Term/Code Not Available | Insufficient Information | K130365 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=14160860&pc=OQG | 1644408-2022-00514 | 2022-04-04 | Injury | ENCORE MEDICAL L.P. | 2022-04-20 | OQG | X-ALT HIP | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=14117314&pc=OQG | 0001822565-2022-01024 | 2022-03-21 | Injury | ZIMMER BIOMET, INC. | 2022-04-15 | OQG | VIT E LINER ELEVATED KK 36 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=14083983&pc=OQG | 9610612-2022-00098 | 2022-03-22 | Injury | AESCULAP AG | 2022-04-12 | OQG | VITELENE INSERT E 32MM SYM. | Patient-Device Incompatibility | Failure of Implant | K122783 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=13993688&pc=OQG | 3002806535-2022-00199 | 2021-12-07 | Injury | BIOMET UK LTD. | 2022-04-04 | OQG | CER BIOLOXD OPTION HD 28MM | Device Dislodged or Dislocated | Joint Dislocation | K192683 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=13901595&pc=OQG | 0001825034-2022-00689 | 2022-03-01 | Injury | ZIMMER BIOMET, INC. | 2022-03-25 | OQG | G7 FINNED 4 HOLE SHELL 56F | Malposition of Device | Failure of Implant | K142746 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=13577303&pc=OQG | 1644408-2022-00244 | 2022-02-07 | Injury | ENCORE MEDICAL L.P | 2022-02-22 | OQG | X-ALT HIP | Appropriate Term/Code Not Available | Insufficient Information | K130365 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=13548627&pc=OQG | 1644408-2022-00240 | 2022-01-24 | Injury | ENCORE MEDICAL L.P. | 2022-02-17 | OQG | FMP HIP | Appropriate Term/Code Not Available | Unspecified Infection | K140130 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=13534214&pc=OQG | 1644408-2022-00215 | 2022-01-25 | Injury | ENCORE MEDICAL L.P | 2022-02-15 | OQG | X-ALT HIP | Appropriate Term/Code Not Available | Unspecified Infection | K130365 | 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. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=13514932&pc=OQG | 1644408-2022-00188 | 2022-01-26 | Injury | ENCORE MEDICAL L.P. | 2022-02-11 | OQG | X-ALT HIP | Appropriate Term/Code Not Available | Unspecified Infection | K130365 | 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. |