Adverse Events Total Hip and Direct Anterior Replacement 2014
Adverse Events Replacement Precautions and Total Hip Replacement 2014
Adverse Events Knee Replacement and Total Hip Replacement 2014
Adverse Events Total Knee Replacement and Total Hip Replacement 2014
Keywords
Direct Anterior
Replacement Precautions
Knee Replacement
Total Knee Replacement
Direct Anterior Knee Replacement
Medical Devices
Adverse Events Total Hip Replacement 2014
This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 2014 through December 2014.
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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 2014 through December 2014. 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
2014-01-01
Last Modified
2015-01-06
Version
2015-01-06
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 2014, Adverse Events Replacement Precautions and Total Hip Replacement 2014, Adverse Events Knee Replacement and Total Hip Replacement 2014, Adverse Events Total Knee Replacement and Total Hip Replacement 2014
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
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED AS LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND LEG LENGTH DISCREPANCY. THE PATIENT'S OPERATIVE REPORT NOTED DARK COLORED SYNOVIAL FLUID. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL PATIENT'S BLOOD WAS TESTED ON (B)(6) 2013.PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED AS LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED. Manufacturer Narrative: THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.AND NUMBER 7 STATES, UNDESIRABLE SHORTENING OF LIMB. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES,MATERIAL SENSITIVITY REACTIONS., NUMBER 14. ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT: REFERENCE 1825034-2013-06204 / 06206). PREVIOUS MEDWATCH REPORT WAS SUBMITTED FOR THIS PATIENT: REFERENCE 1825034-2012-01907.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED AS LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED.PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED AS LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND LEG LENGTH DISCREPANCY. THE PATIENT'S OPERATIVE REPORT NOTED DARK COLORED SYNOVIAL FLUID. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL PATIENT'S BLOOD WAS TESTED ON (B)(6) 2013. Manufacturer Narrative: THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACESAND NUMBER 7 STATES,UNDESIRABLE SHORTENING OF LIMB. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES,MATERIAL SENSITIVITY REACTIONS., NUMBER 14. ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT: REFERENCE 1825034-2013-06204 / 06206). PREVIOUS MEDWATCH REPORT WAS SUBMITTED FOR THIS PATIENT: REFERENCE 1825034-2012-01907.
PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED AS LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL PATIENT UNDERWENT RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND LEG LENGTH DISCREPANCY. THE PATIENT'S OPERATIVE REPORT NOTED DARK COLORED SYNOVIAL FLUID. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL PATIENT'S BLOOD WAS TESTED ON (B)(6) 2013.PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2010. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURIES. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED AS LEGAL COUNSEL REPORTED PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. THIS REPORT IS BASED ON PATIENT ALLEGATIONS AND THE ALLEGATIONS ARE CURRENTLY UNKNOWN AND UNVERIFIED. Manufacturer Narrative: THIS FOLLOW-UP IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.AND NUMBER 7 STATES, UNDESIRABLE SHORTENING OF LIMB. Manufacturer Narrative: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES,MATERIAL SENSITIVITY REACTIONS., NUMBER 14. ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT: REFERENCE 1825034-2013-06204 / 06206). PREVIOUS MEDWATCH REPORT WAS SUBMITTED FOR THIS PATIENT: REFERENCE 1825034-2012-01907.
ALLEGEDLY PT. WAS REVISED DUE TO MOM COMPLICATIONS. Manufacturer Narrative: INVESTIGATION IS NOT COMPLETE. EVENT CODE IS ADDRESSED IN PACKAGE INSERT. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 1043534-2013-02678, -02680. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED. Manufacturer Narrative: (B)(4).
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT: BILATERAL PATIENT. LITIGATION PAPERS ALLEGE: PATIENT HAD LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES RELEASED INTO BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANTS; PATIENT SUFFERED FROM PAIN AROUND THE HIP JOINT, DIFFICULTY WALKING, ACLICKING, MUSCLE AND BONE SEPARATION AND SWELLING; LARGE PSEUDO-TUMOR IN LEFT HIP; SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN BOTH THIGHS AND HHIP AREAS; EXTREME DISCOMFORT WHEN SITTING FOR PERIODS OF TIME. DOI: (B)(6) 2005 - DOR: (B)(6) 2011 (LEFT SIDE). DOI: (B)(6) 2005 - DOR: (B)(6) 2011 (RIGHT SIDE). UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. THE PATIENT WAS REVISED ON BOTH SIDES BECAUSE OF PAIN AND CORROSION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEVICE NOT RETURNED. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. Manufacturer Narrative: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. X-RAYS WERE OBTAINED AND REVIEWED BY A DEPUY LEGAL NURSE. 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.
NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: BILATERAL PATIENT LITIGATION PAPERS ALLEGE: PATIENT HAD LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES RELEASED INTO BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANTS; PATIENT SUFFERED FROM PAIN AROUND THE HIP JOINT, DIFFICULTY WALKING, ACLICKING, MUSCLE AND BONE SEPARATION AND SWELLING; LARGE PSEUDO-TUMOR IN LEFT HIP; SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN BOTH THIGHS AND HHIP AREAS; EXTREME DISCOMFORT WHEN SITTING FOR PERIODS OF TIME. DOI: (B)(6) 2005 - DOR: (B)(6) 2011 (LEFT SIDE); DOI: (B)(6) 2005 - DOR: (B)(6) 2011 (RIGHT SIDE). UPDATE: (B)(4) 2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. THE PATIENT WAS REVISED ON BOTH SIDES BECAUSE OF PAIN AND CORROSION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. Manufacturer Narrative: ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. X-RAYS WERE OBTAINED AND REVIEWED BY A DEPUY LEGAL NURSE. 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. DEVICE NOT RETURNED.
PATIENT WAS REVISED TO ADDRESS STEM MALPOSITIONING. IT WAS REPORTED THAT THE STEM SPUN OUT IN FEMORAL CANAL AND FELL INTO RETROVERSION.PATIENT WAS REVISED TO ADDRESS STEM LOOSENING. IT WAS REPORTED THAT THE STEM SPUN OUT IN FEMORAL CANAL AND FELL INTO RETROVERSION. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. Manufacturer Narrative: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT WAS REVISED TO ADDRESS STEM LOOSENING. IT WAS REPORTED THAT THE STEM SPUN OUT IN FEMORAL CANAL AND FELL INTO RETROVERSION. DOI: (B)(6) 2013 DOR: (B)(6) 2013 (RIGHT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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
CONFIRMED REVISION OF PINNACLE HIP. REASON FOR REVISION UNKNOWN.. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. Manufacturer Narrative: ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. NO REASON FOR REVISION HAS BEEN PROVIDED AND THEREFORE NO CONCLUSIONS CAN BE DRAWN. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION.
UPDATE JAN 10, 2014: PRODUCT/LOT INFORMATION.CONFIRMED REVISION OF PINNACLE HIP. REASON FOR REVISION UNKNOWN. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION Manufacturer Narrative: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. NO REASON FOR REVISION HAS BEEN PROVIDED AND THEREFORE NO CONCLUSIONS CAN BE DRAWN. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEVICE RETURNED.
SHE WAS COMPLAINING TO HER SURGEON ON PAIN IN HER LEGS, AND UNDERWENT VARIOUS EXAMS BY HER SURGEON AND VARIOUS PHYSICIANS. SHE HAD A REVISION SURGERY (B)(6) 2011. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. Manufacturer Narrative: NOTIFICATION WAS RECEIVED FROM BIOENGINEERING STATING THAT THE ROOT CAUSE IS UNDETERMINED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE CUSTOMER DID NOT REPORT A DEVICE DEFECT. IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A MANUFACTURING FAULT. NO CORRECTIVE ACTION IS REQUIRED. A REVIEW OF COMPLAINTS DATABASE SEARCH AND MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. Manufacturer Narrative: FOLLOWING RECEIPT OF PRODUCTS, FURTHER INVESTIGATION WAS COMPLETED WHICH CONFIRMED THAT THE RETURNED PRODUCTS HAD BEEN MANUFACTURED CORRECTLY TO SPECIFICATION. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. Manufacturer Narrative: A REVIEW OF THE INFORMATION PROVIDED IDENTIFIED THAT INSUFFICIENT INFORMATION HAD BEEN PROVIDED TO COMPLETE AN INVESTIGATION. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. Manufacturer Narrative: THIS COMPLAINT IS STILL UNDER INVESTIGATION. NOT RETURNED.
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