Adverse Events Total Hip and Direct Anterior Replacement 2015
Adverse Events Replacement Precautions and Total Hip Replacement 2015
Adverse Events Knee Replacement and Total Hip Replacement 2015
Adverse Events Total Knee Replacement and Total Hip Replacement 2015
Keywords
Direct Anterior
Replacement Precautions
Knee Replacement
Total Knee Replacement
Direct Anterior Knee Replacement
Medical Devices
Adverse Events Total Hip Replacement 2015
This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 2015 through December 2015.
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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 2015 through December 2015. 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.
About this Dataset
Data Info
Date Created
2015-01-01
Last Modified
2016-01-06
Version
2016-01-06
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 2015, Adverse Events Replacement Precautions and Total Hip Replacement 2015, Adverse Events Knee Replacement and Total Hip Replacement 2015, Adverse Events Total Knee Replacement and Total Hip Replacement 2015
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
string
-
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
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO WEAR. Manufacturer Narrative: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS SIGNS OF WEAR/USE ESPECIALLY ON THE EDGE OF THE INNER DIAMETER. A REVIEW OF THE MANUFACTURING HISTORY RECORD REVEALED DISCREPANCIES DURING THE MANUFACTURING PROCESS; HOWEVER, PER PROCEDURE THE REMAINDER OF THE ORDER WAS 100% INSPECTED. A LAB ANALYSIS WAS COMPLETED AND THE RESULTS WERE DAMAGE OBSERVED ON THE OUTSIDE DIAMETER OF THE FEMORAL HEAD REVEALED COMPOSITIONAL ELEMENTS OF TI6AL4V INDICATING THAT CONTACT BETWEEN THE HEAD AND ACETABULAR SHELL COULD HAVE OCCURRED DURING EITHER DISLOCATION/REDUCTION) OR IMPLANTATION/EXTRACTION. ADDITIONAL DAMAGE WAS OBSERVED ON THE UNDERSIDE OF THE FEMORAL HEAD REVEALED COMPOSITIONAL ELEMENTS OF STAINLESS STEEL INDICATING CONTACT WITH A SURGICAL INSTRUMENT WAS POSSIBLE. DEFORMATION/BURNISHING, MAYBE CAUSED BY IMPINGEMENT WITH THE NECK OF THE FEMORAL STEM, WAS OBSERVED ON THE OVERHANG OF THE LINER. AREAS OF DAMAGE WERE OBSERVED ON THE FACE OF THE LINER AND ON ANTI-ROTATION TAB POSSIBLY CAUSED FROM EXTRACTION. DISCOLORATION DUE TO ABSORPTION OF BIOLOGICAL FLUID WAS OBSERVED ON THE BACKSIDE OF THE LINER. BURNISHING AND LIGHT SCRATCHING WERE OBSERVED ON THE ARTICULATING SURFACE OF THE LINER. TOTAL LINEAR PENETRATION WAS ESTIMATED TO BE 0.2 MM USING SILICONE MOLD REPLICATION. NO UNUSUAL WEAR FEATURES WERE SEEN ON THE ACETABULAR LINER. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. Manufacturer Narrative: .
REVISION SURGERY - DUE TO PATIENT DEVELOPING ARTHRITIS, THE SURGEON CHANGED TO TOTAL HIP. Manufacturer Narrative: ENTERED DATE RECEIVED BY MANUFACTURER ON 1644408-2014-00814_FU1 INCORRECTLY AS 07/27/2015; SHOULD BE 05/27/2015. Manufacturer Narrative: THE REASON FOR THIS REVISION SURGERY WAS TO CHANGE TO A TOTAL HIP AFTER 6.5 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THE MAIN CONTRIBUTOR COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST A PART FROM THIS LOT NUMBER. THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE RESULT/ROOT CAUSE OF THE PATIENT'S ARTHRITIS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST A PART FORM THIS LOT NUMBER.
PATIENT WAS REVISED TO ADDRESS PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND TRUNNIONOSIS. Manufacturer Narrative: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. Manufacturer Narrative: ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
PATIENT WAS REVISED TO ADDRESS PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND TRUNNIONS. Manufacturer Narrative: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
PATIENT WAS REVISED TO ADDRESS PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND TRUNNIONOSIS. Manufacturer Narrative: ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). Manufacturer Narrative: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
PATIENT WAS REVISED TO ADDRESS POSSIBLY INFECTION, HOWEVER, CULTURES CAME BACK NEGATIVE FOR INFECTION. IT WAS ALSO NOTED THAT THE ACETABULAR CUP WAS GROSSLY LOOSE. UPDATE REC'D (B)(6) 2014 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2015. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Manufacturer Narrative: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).
PATIENT WAS REVISED TO ADDRESS INFECTION. Manufacturer Narrative: ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
REPORT OF FORMAL CLAIM RECEIVED FROM (B)(4) REGARDING REVISION OF PINNACLE MOM HIP IMPLANTS. DATE OF REVISION CONFIRMED, REASON FOR REVISION NOT PROVIDED. Manufacturer Narrative: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. Manufacturer Narrative: ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
REPORT OF FORMAL CLAIM RECEIVED FROM KENNEDYS REGARDING REVISION OF PINNACLE MOM HIP IMPLANTS. DATE OF REVISION CONFIRMED, REASON FOR REVISION NOT PROVIDED. Manufacturer Narrative: COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Manufacturer Narrative: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
REPORT OF FORMAL CLAIM RECEIVED FROM KENNEDYS REGARDING REVISION OF PINNACLE MOM HIP IMPLANTS. DATE OF REVISION CONFIRMED, REASON FOR REVISION NOT PROVIDED. Manufacturer Narrative: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. Manufacturer Narrative: THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Demos
