Others titles
- Adverse Events Total Hip and Direct Anterior Replacement 2016
- Adverse Events Replacement Precautions and Total Hip Replacement 2016
- Adverse Events Knee Replacement and Total Hip Replacement 2016
- Adverse Events Total Knee Replacement and Total Hip Replacement 2016
Keywords
- Direct Anterior
- Replacement Precautions
- Knee Replacement
- Total Knee Replacement
- Direct Anterior Knee Replacement
- Medical Devices
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.
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Description
This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2016 through December 31, 2016. 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.
About this Dataset
Data Info
Date Created | 2016-01-01 |
---|---|
Last Modified | 2016-12-31 |
Version | 2016-12-31 |
Update Frequency |
Annual |
Temporal Coverage |
2014-01-01 to 2014-12-31 |
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 2016, Adverse Events Replacement Precautions and Total Hip Replacement 2016, Adverse Events Knee Replacement and Total Hip Replacement 2016, Adverse Events Total Knee Replacement and Total Hip Replacement 2016 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Web_Address | Website link to adverse event report | string | required : 1 |
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 | - |
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 | Event Description |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6216297&pc=NRA | 3002806535-2016-00930 | 2016-12-05 | Injury | BIOMET UK LTD. | 2016-12-30 | NRA | OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING | PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE 19 DAYS POST-IMPLANTATION DUE TO DISLOCATION OF THE BEARING. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4), MEDICAL PRODUCT - PN: 154926 LN: 3861276 CEMENTLESS MEDIUM FEMUR, PN: 166576 LN: 3808969 CEMENTLESS LEFT MEDIAL TIBIAL TRAY SIZE D. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6216299&pc=NRA | 3002806535-2016-00929 | 2016-12-01 | Malfunction | BIOMET UK LTD. | 2016-12-30 | NRA | OXFORD PARTIAL KNEE CONCISE INSTRUMENT TIBIAL RESECTOR STYLUS | IT WAS FOUND THE G-CLAMP INSTRUMENT WAS DAMAGED, AS ONE OF THE SCREWS WAS NO LONGER SEALED. THIS WAS FOUND OUTSIDE OF A PROCEDURE, WITH NO PATIENT IMPACT. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6216402&pc=NRA | 3002806535-2016-00935 | 2016-12-18 | Injury | BIOMET UK LTD. | 2016-12-30 | NRA | UNKNOWN OXFORD KNEE | PATIENT REPORTED RIGHT KNEE REVISION PROCEDURE APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO UNSPECIFIED REASONS. THE PATIENT WAS CONVERTED FROM A PARTIAL KNEE SYSTEM TO TOTAL KNEE SYSTEM. Manufacturer Narrative: THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6216529&pc=NRA | 3002806535-2016-00925 | 2016-11-29 | Injury | BIOMET UK LTD. | 2016-12-30 | NRA | OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING | PATIENT UNDERWENT A KNEE REVISION DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6216530&pc=NRA | 3002806535-2016-00937 | 2016-11-22 | Injury | BIOMET UK LTD. | 2016-12-30 | NRA | OXFORD MENISCAL BEARING COMPONENT | PATIENT UNDERWENT A RIGHT KNEE REVISION AND IRRIGATION AND DEBRIDEMENT PROCEDURE SIX DAYS POST-IMPLANTATION DUE TO AN UNKNOWN REASON. THE POLYETHYLENE TIBIAL BEARING WAS REMOVED AND REPLACED. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. UNIQUE IDENTIFIER (UDI) # - (B)(4). MEDICAL PRODUCT - PN: 161470 LN: 166350 OXFORD FEMORAL COMPONENT, PN: 154727 LN: 1807863 OXFORD TIBIAL TRAY. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6213400&pc=NRA | 3002806535-2016-00932 | 2016-10-31 | Injury | BIOMET UK LTD. | 2016-12-29 | NRA | OXFORD TWIN PEG FEMORAL | IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN 12 MONTHS POST IMPLANTATION. Manufacturer Narrative: (B)(4). CONCOMITANT MEDICAL PRODUCTS - MEDICAL PRODUCT - OXFORD RIGHT MEDIAL TIBIAL TRAY, CATALOG#: 154719, LOT#: 271520. OXFORD BEARING, CATALOG#: 159574, LOT#: 2777776. EVENT IS BEING REPORTED TO FDA ON THREE MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535 - 2016 - 00933 / 3002806535 - 2016 - 00934 ). |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6213523&pc=NRA | 3002806535-2016-00933 | 2016-10-31 | Injury | BIOMET UK LTD. | 2016-12-29 | NRA | OXFORD RIGHT MEDIAL TIBIAL TRAY | IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN 12 MONTHS POST IMPLANTATION. Manufacturer Narrative: (B)(4). CONCOMITANT MEDICAL PRODUCT: OXFORD TWIN PEG FEMORAL CATALOG# 161468 LOT# 702900, OXFORD BEARING CATALOG# 159574, LOT# 2777776. EVENT IS BEING REPORTED TO FDA ON THREE MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 2 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 3002806535 - 2016 - 00932 / 3002806535 - 2016 - 00934). |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6214325&pc=NRA | 3002806535-2016-00934 | 2016-10-31 | Injury | BIOMET UK LTD. | 2016-12-29 | NRA | OXFORD BEARING RIGHT SIZE 9 | IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN 12 MONTHS POST IMPLANTATION. Manufacturer Narrative: CONCOMITANT PRODUCTS: OXFORD TWIN PEG FEMORAL CATALOG# 161468 LOT# 702900, OXFORD RIGHT MEDIAL TIBIAL TRAY CATALOG# 154719 LOT# 271520. EVENT IS BEING REPORTED TO FDA ON THREE MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535 - 2016 - 00932 / 3002806535 - 2016 - 00933). |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6214473&pc=NRA | 3002806535-2016-00923 | 2016-11-28 | Injury | BIOMET UK LTD. | 2016-12-29 | NRA | OXFORD TIBIAL TRAY SIZE AA LM | PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE DUE TO LOOSE TIBIAL COMPONENT. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: PN: 161468 LN: 301760 OXFORD TWIN-PEG FEMORAL COMPONENT. PN: 159542 LN: 160660 OXFORD BEARING SIZE 5. |
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=6210545&pc=NRA | 3002806535-2016-00921 | 2016-02-17 | Injury | BIOMET UK LTD. | 2016-12-28 | NRA | OXFORD CEMENTLESS TIBIA D RM | PATIENT REPORTED EXPERIENCING RIGHT KNEE PAIN, DISCOMFORT AND RADIOLUCENCY NEAR TIBIAL COMPONENT. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CONCOMITANT PRODUCTS: 161475 LOT 2407054 OXFORD TWIN PEG CEMENTLESS FEMORAL, 159583 LOT 377130 OXFORD ANATOMICAL BEARING RIGHT. |