Adverse Events Total Hip and Direct Anterior Replacement 2017
Adverse Events Replacement Precautions and Total Hip Replacement 2017
Adverse Events Knee Replacement and Total Hip Replacement 2017
Adverse Events Total Knee Replacement and Total Hip Replacement 2017
Keywords
Direct Anterior
Replacement Precautions
Knee Replacement
Total Knee Replacement
Direct Anterior Knee Replacement
Medical Devices
Adverse Events Total Hip Replacement 2017
This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2017 through December 31, 2017.
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This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2017 through December 31, 2017. 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
2017-01-01
Last Modified
2017-12-31
Version
2017-12-31
Update Frequency
Annual
Temporal Coverage
2017-01-01 to 2017-12-31
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 2017, Adverse Events Replacement Precautions and Total Hip Replacement 2017, Adverse Events Knee Replacement and Total Hip Replacement 2017, Adverse Events Total Knee Replacement and Total Hip Replacement 2017
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
DURING EXTRACTION OF A 100 MM CANNULATED SCREW, THE SURGEON NOTED THAT THE TIP BROKE OFF FROM THE THREADED FLUTE. DETACHED PIECE WAS FROM THE CUTTING TIP WITH A LENGTH OF 1.5- 2 MM. CANNULATED SCREW SENT TO BIOMEDICAL ENGINEERING FOR RECORDING AND DELIVERY TO MANUFACTURER FOR ANALYSIS OF FAILURE. CASE PROCEEDED WITHOUT ADDITIONAL COMPLICATION OR HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR 100 MM X 7.3 MM CANNULATED SCREW, SYNTHES (PER SITE REPORTER): AWAITING FOLLOW UP AND RETURN INSTRUCTIONS. Manufacturer Narrative: .
IT WAS REPORTED THAT THE DEVICE DID NOT DEPLOY. NO PATIENT INJURIES WERE REPORTED. SURGICAL DELAY WAS REPORTED FOR OVER 30 MIN.Manufacturer Narrative: REPORT WAS INADVERTENTLY SUBMITTED UNDER MANUFACTURER NUMBER 1219602 BUT THE CORRECT MANUFACTURER NUMBER IS 3006524618. Manufacturer Narrative: THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION OF THE RETURNED OPUS SPEEDSCREW IMPLANT SHOWS A PARTIALLY DEPLOYED DEVICE WITH A DAMAGED IMPLANT. THE PARTS OF THE BROKEN ANCHOR WERE RETURNED. BOTH SUTURE LIMBS WERE REELED INTO THE WHEELS AND ARE CONTAMINATED WITH UNKNOWN BLOODY SUBSTANCES. NO MANUFACTURING ANOMALIES WERE IDENTIFIED. DURING FUNCTIONAL EVALUATION THE ACTIVATION KNOB COULD BE EASILY TURNED. THE FUNCTION SWITCH CAN BE SET TO THE GREEN- OR BLACK DOT POSITION TO TURN THE ACTIVATION KNOB. THE FUNCTION SWITCH COULD BE PRESSED DOWN AND MOVED FORWARD. TO DEPLOY THE SUTURE LOCK BY TURNING THE ACTIVATION KNOB IS NOT POSSIBLE ANY MORE. THE ACTIVATION KNOB IS FIXED. THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT INCLUDE: THERE MAY HAVE BEEN MISALIGNMENT OF THE DEVICE WHEN INSERTING ,BEND AND APPLYING EXCESSIVE TORQUE COULD CAUSE DAMAGE TO THE IMPLANT. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. Manufacturer Narrative: .
IT WAS REPORTED THAT DURING THE PROCEDURE THE DRIVER TWISTED. A SOLID DRIVER WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. Manufacturer Narrative: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL ANALYSIS CONFIRMS THAT THE TIP OF THE DRIVER IS TWISTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE FAILURE IS RELATED TO PLASTIC DEFORMATION AS A RESULT OF THE DESIGN OF THE DEVICE. THESE DRIVERS HAVE BEEN DESIGNED TO TWIST BEFORE FRACTURE OF THE SCREW. AS PART OF PREVIOUS INVESTIGATION, COMMUNICATION WAS SENT TO THE FIELD WITH ADVICE ABOUT HOW TO USE THE DRIVERS CORRECTLY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE BROKE POSTOPERATIVELY. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2016. THE REVISION OF THE PLATE WILL BE PERFORMED WITH ANOTHER COMPETITIVE PLATE (BRAND NAME AND ARTICLE NUMBER ARE UNKNOWN). TWO (2) UNKNOWN SCREWS WERE RETURNED BROKEN. UNKNOWN WHEN OR HOW THE SCREWS BROKE. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT AND SURGICAL OUTCOME. THIS COMPLAINT INVOLVES 2 PARTS. CONCOMITANT DEVICES: 6X UNK SCREWS. (B)(4). Manufacturer Narrative: DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR (2) UNKNOWN SCREWS /UNKNOWN LOT NUMBER. LOT NUMBER UNKNOWN. UDI UNAVAILABLE. EXPLANT DATE IS UNKNOWN. (B)(6). 510K#: UNKNOWN. THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO LOT NUMBER WAS PROVIDED. DEVICE RECEIVED IN A CONDITION MAKING EVALUATION IMPOSSIBLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH AN UNKNOWN TIBIAL NAIL AND SCREWS ON (B)(6) 2016. DURING A FOLLOW UP VISIT ON (B)(6) 2017 IT WAS NOTED THAT THE 5.0MM PROXIMAL LOCKING SCREW WAS BACKING OUT OF THE TIBIAL NAIL AND SLIGHTLY PROTRUDING. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY PAIN OR OTHER SYMPTOMS. SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2017 WHERE THE PROXIMAL LOCKING SCREW WAS REMOVED. PATIENT WAS NOT REVISED TO A NEW SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: TIBIAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Manufacturer Narrative: ADDITIONAL NARRATIVE: (B)(6). DATE OF DEVICE MIGRATION IS NOT KNOWN. 510K: THIS REPORT IS FOR AN UNKNOWN 5.0MM PROXIMAL LOCKING SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL OF A LATERAL ENTRY RECON NAIL IN THE RIGHT FEMUR ON (B)(6) 2017 DUE TO NON-UNION AND THREE (3) PROXIMALLY LOCATED 5.0 MM LOCKING SCREWS THAT WERE DISCOVERED TO BE BROKEN. THE PATIENT HAD INITIALLY BEEN IMPLANTED WITH ONE (1) LATERAL ENTRY RECON NAIL, THREE (3) PROXIMAL 5.0 MM LOCKING SCREWS AND TWO (2) DISTAL RECON SCREWS FOR A SUBTROCHANTERIC FRACTURE REPAIR ON AN UNKNOWN DATE FEW YEARS BACK. ON A FOLLOW-UP VISIT, X-RAYS REVEALED THE NON-UNION AND BROKEN SCREWS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITHOUT ANY SURGICAL DELAYS AND THE PATIENT WAS REVISED TO A DYNAMIC HIP SYSTEM (DHS) 10-HOLE 135 MM PLATE WITH ONE (1) 95 MM LAG SCREW. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: RECON SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 2); LATERAL ENTRY RECON NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). FURTHER IT WAS CLARIFIED THAT THE 2 RECON SCREWS WERE LOCATED PROXIMALLY AND THE 3 BROKEN 5.0 MM LOCKING SCREWS WERE DISTALLY LOCATED AS OPPOSED TO PREVIOUSLY REPORTED. Manufacturer Narrative: (B)(6). PATIENT GENDER AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE AND NON-UNION IS NOT KNOWN. THIS REPORT IS FOR THREE (3) UNKNOWN 5.0 MM LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT IS NOT KNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS SYNTHES SALES CONSULTANT WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SET SCREW HAD BEEN DISLODGED POSTOPERATIVELY ON AN UNKNOWN DATE. X-RAYS TAKEN ON AN UNKNOWN DATE DETERMINED THAT THE SCREW HAD MIGRATED. REVISION SURGERY WILL BE REQUIRED BUT IS NOT CURRENTLY SCHEDULED. IT IS UNKNOWN WHEN THE ORIGINAL SURGERY TOOK PLACE. (B)(4). Manufacturer Narrative: ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ORIGINAL IMPLANT DATE IS UNKNOWN, DEVICE IS STILL IMPLANTED. DEVICE IS NOT EXPECTED TO RETURN; IT IS CURRENTLY STILL IMPLANTED. CONTACT PHONE NUMBER IS NOT AVAILABLE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SET SCREW HAD BEEN DISLODGED POSTOPERATIVELY ON AN UNKNOWN DATE. X-RAYS TAKEN ON AN UNKNOWN DATE DETERMINED THAT THE SCREW HAD MIGRATED. REVISION SURGERY WILL BE REQUIRED BUT IS NOT CURRENTLY SCHEDULED. IT IS UNKNOWN WHEN THE ORIGINAL SURGERY TOOK PLACE. (B)(4). Manufacturer Narrative: ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ORIGINAL IMPLANT DATE IS UNKNOWN, DEVICE IS STILL IMPLANTED. DEVICE IS NOT EXPECTED TO RETURN; IT IS CURRENTLY STILL IMPLANTED. CONTACT PHONE NUMBER IS NOT AVAILABLE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) EXTRA-ARTICULAR PROXIMAL ULNA PLATE APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. PATIENT PRESENTED WITH PUS DRAINAGE FROM THE INCISION AND WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE VA LCP EXTRA-ARTICULAR PROXIMAL ULNA PLATE, THREE (3) 3.5MM CORTICAL SCREWS, TWO (2) 3.5MM LOCKING SCREWS, AND SIX (6) 2.7MM VA LOCKING SCREWS. PATIENT WAS REVISED TO ANTIBIOTIC BEADS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. (B)(4). Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Manufacturer Narrative: ADDITIONAL NARRATIVE: PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE INFECTION BEGAN IS NOT KNOWN. 510K: THIS REPORT IS FOR THREE (3) UNKNOWN 3.5MM CORTICAL SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT REPORTED AS APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) EXTRA-ARTICULAR PROXIMAL ULNA PLATE APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. PATIENT PRESENTED WITH PUS DRAINAGE FROM THE INCISION AND WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED THE VA LCP EXTRA-ARTICULAR PROXIMAL ULNA PLATE, THREE (3) 3.5MM CORTICAL SCREWS, TWO (2) 3.5MM LOCKING SCREWS, AND SIX (6) 2.7MM VA LOCKING SCREWS. PATIENT WAS REVISED TO ANTIBIOTIC BEADS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS IS REPORT 3 OF 4 FOR (B)(6)Manufacturer Narrative: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. Manufacturer Narrative: PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE INFECTION BEGAN IS NOT KNOWN. PMA 510K: THIS REPORT IS FOR TWO (2) UNKNOWN 3.5MM LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANT REPORTED AS APPROXIMATELY 6 MONTHS PRIOR TO REMOVAL. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Demos
