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Others titles
- Adverse Events Total Hip and Direct Anterior Replacement 2021
- Adverse Events Replacement Precautions and Total Hip Replacement 2021
- Adverse Events Knee Replacement and Total Hip Replacement 2021
- Adverse Events Total Knee Replacement and Total Hip Replacement 2021
Keywords
- Direct Anterior
- Replacement Precautions
- Knee Replacement
- Total Knee Replacement
- Direct Anterior Knee Replacement
- Medical Devices
Adverse Events Total Hip Replacement 2021
This dataset identifies adverse events associated with medical devices for total hip replacement. This dataset includes reports submitted from January 01, 2021 through December 31, 2021.
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Description
This dataset includes reports submitted to the Food and Drug Administration (FDA) from January 01, 2021 through December 31, 2021. 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 | 2021-04-18 |
|---|---|
| Last Modified | 2022-04-29 |
| Version | 2022-04-29 |
| Update Frequency |
Annual |
| Temporal Coverage |
2021-01-01 to 2021-12-31 |
| 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 2021, Adverse Events Replacement Precautions and Total Hip Replacement 2021, Adverse Events Knee Replacement and Total Hip Replacement 2021, Adverse Events Total Knee Replacement and Total Hip Replacement 2021 |
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=11600181&pc=MNT | 2031642-2021-03196 | 2021-03-02 | Malfunction | RESPIRONICS CALIFORNIA, LLC | 2021-03-31 | MNT | RESPIRONICS | Inadequate User Interface | No Clinical Signs, Symptoms or Conditions | K102985 | Event Description: IT WAS REPORTED THAT THE VENTILATOR'S NAVIGATION RING FAILED. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. THERE WAS NO HARM REPORTED. Manufacturer Narrative: ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. THERE WAS NO HARM REPORTED. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600182&pc=HRS | 0008031020-2021-00115 | 2021-03-05 | Malfunction | STRYKER GMBH | 2021-03-31 | HRS | LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L50MM | Material Fragmentation | No Clinical Signs, Symptoms or Conditions | K132502 | Event Description: AS REPORTED: "DURING THE SCREW INSERTION OF THE DISTAL HUMERUS, WHAT SEEMS TO BE A THREAD HAS COME OFF, THE SCREW WAS REPLACED IT WITH A NEW SCREW". Manufacturer Narrative: UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600183&pc=DSQ | 2916596-2021-01655 | 2019-03-20 | Injury | THORATEC CORPORATION | 2021-03-31 | DSQ | HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) | Adverse Event Without Identified Device or Use Problem | Abdominal Pain; Abdominal Distention; Gastrointestinal Hemorrhage; Melena | P060040 | Event Description: IT WAS REPORTED THAT THE PATIENT WAS ADMITTED (B)(6) 2019 FOR MELENA IN STOOL AND ABDOMINAL DISTENSION/PAIN. HEMOGLOBIN WAS DOWN TO 7.7 G/DL. A KIDNEY, URETER, AND BLADDER (KUB) X-RAY ON (B)(6) SHOWED DILATED LOOP OF BOWEL CONCERNING FOR ILEUS. BOWEL REGIMEN INCREASED WITH IMPROVEMENT IN PAIN. COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN ON (B)(6) SHOWED THICKENING GALLBLADDER. CHOLESCINTIGRAPHY SCAN ON (B)(6) DID NOT SHOW ACUGLOBIN WTE CHOLECYSTITIS , BUT THERE WERE TRACES OF DELAYED TRACER UPTAKE INDICATIVE OF HEPATOCELLULAR. LIVER-FUNCTION TESTS WERE ALSO ELEVATED. RIGHT UPPER QUADRANT (RUQ) ULTRASOUND WITH DOPPLER WAS NEGATIVE FOR ACUTE FINDING. BLEEDING STOPPED AND HEMOGLOBIN AND HEMATOCRIT STABILIZED. PATIENT WAS DISCHARGED (B)(6) 2019. Manufacturer Narrative: HISTORY OF GASTROINTESTINAL BLEEDING REPORTED IN MFRS# 2916596-2021-01651, #2916596-2021-01611, #2916596-2021-01652, #2916596-2021-01653, #2916596-2021-01654, #2916596-2021-01656, #2916596-2021-01581, #2916596-2021-01559, #2916596-2021-01658. ADMISSION FOR SMALL BOWEL OBSTRUCTION/DRIVELINE ADHESION REPORTED IN MFR #2916596-2021-01657. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF GASTROINTESTINAL (GI) BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. GI BLEEDING HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600184&pc=QBJ | 3004753838-2021-60571 | 2021-03-08 | Malfunction | DEXCOM, INC. | 2021-03-31 | QBJ | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | No Device Output | No Clinical Signs, Symptoms or Conditions | DEN170088 | Event Description: IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. Manufacturer Narrative: (B)(4). |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600185&pc=BTT | 9611451-2021-00332 | 2021-02-09 | Injury | FISHER & PAYKEL HEALTHCARE LTD | 2021-03-31 | BTT | AIRVO2 HUMIDIFIER | Device Displays Incorrect Message | Low Oxygen Saturation | K131895 | Event Description: A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A PATIENT USING THE PT101 AIRVO 2 HUMIDIFIER DESATURATED TO 60% SPO2 FOLLOWING AN INCIDENT WHERE THE AIRVO 2 HUMIDIFIER DISPLAYED ERROR CODE E146. ON (B)(6) 2021 IT WAS FURTHER REPORTED THAT THE PATIENT WAS PROVIDED MANUAL VENTILATION USING A BAG VALVE MASK. THE PATIENT THEN EXPERIENCED AN ANXIETY ATTACK AND THE HOSPITAL REPORTED THAT THIS RESULTED IN AN INCREASED RESPIRATORY RATE AND DECREASING OXYGEN SATURATION. THE PATIENT WAS THEN INTUBATED AND PLACED ON A VENTILATOR. FOLLOWING THE INTUBATION, THE PATIENT WAS ON VENTILATOR SUPPORT FOR FOUR DAYS BEFORE THE WITHDRAWAL OF LIFE SUPPORT ON (B)(6) 2021. Manufacturer Narrative: (B)(4). WE ARE IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE CUSTOMER TO DETERMINE IF PT101 AIRVO 2 HUMIDIFIER CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600186&pc=OZO | 3013756811-2021-36011 | 2021-03-11 | Malfunction | TANDEM DIABETES CARE | 2021-03-31 | OZO | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | Inappropriate or Unexpected Reset | No Clinical Signs, Symptoms or Conditions | K201214 | Event Description: IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE PUMP RESET WAS PERFORMED CUSTOMER CONTINUED INSULIN THERAPY. Manufacturer Narrative: NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600187&pc=GDW | 3005075853-2021-01677 | 2021-03-02 | Malfunction | ETHICON ENDO-SURGERY, LLC. | 2021-03-31 | GDW | POWERED 60 ECHELON +, 340MM SHAFT | Device Markings/Labelling Problem | No Clinical Signs, Symptoms or Conditions | K110385 | Event Description: IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY OPERATION, THE OPERATING ROOM NURSE PICKED UP WHAT WAS EXPECTED TO BE A 60MM POWER PLUS STAPLER. DESPITE THE MARKING ON BOTH THE KIT AND THE PACKAGING OF THE STAPLER, THEY FOUND A 45MM POWER PLUS STAPLER. THE NURSE CHANGED THE INSTRUMENT AND THE PROCEDURE COULD CONTINUE WITHOUT COMPLICATIONS FOR THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. Manufacturer Narrative: (B)(4). BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AND NO DEVICE HAS BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600188&pc=PZE | 2954323-2021-65157 | 2021-03-21 | Injury | ABBOTT DIABETES CARE INC | 2021-03-31 | PZE | FREESTYLE LIBRE 14 DAY | Adverse Event Without Identified Device or Use Problem | Itching Sensation; Skin Infection; Swelling/ Edema | P160030 | Event Description: A CUSTOMER REPORTED SKIN IRRITATION WHILE WEARING THE ADC FREESTYLE LIBRE SENSOR AND EXPERIENCED INFECTION-LIKE SYMPTOMS DESCRIBED AS SWELLING, REDNESS, AND ITCHING AT THE SENSOR SITE. HCP CONTACT WAS MADE ON (B)(6) 2021 AND THE CUSTOMER WAS PRESCRIBED FLUCLOXACILLIN ANTIBIOTICS AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. Manufacturer Narrative: AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION OR AN ALLERGIC REACTION TO THE PATCH ADHESIVE OF THE FREESTYLE LIBRE SENSOR. DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATES THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR PRODUCTS. ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET ADC MINIMUM REQUIREMENTS FOR PRODUCT QUALITY. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600189&pc=QBJ | 3004753838-2021-60572 | 2021-03-03 | Malfunction | DEXCOM, INC. | 2021-03-31 | QBJ | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | Wireless Communication Problem | No Clinical Signs, Symptoms or Conditions | DEN170088 | Event Description: IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. Manufacturer Narrative: (B)(4). |
| https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=11600190&pc=HQL | 2648035-2021-07469 | 2021-03-03 | Malfunction | AMO PUERTO RICO MFG. INC. | 2021-03-31 | HQL | TECNIS IOL | Break; Mechanical Problem | No Clinical Signs, Symptoms or Conditions | P980040 | Event Description: IT WAS REPORTED THAT THE PISTON PASSED OVER THE INTRAOCULAR LENS (IOL) WHILE PREPARING THE INJECTOR FOR THE IMPLANT. THEN THE DOCTOR OPENED THE INJECTOR IN AN ATTEMPT TO USE THE IOL BUT THE TIP OF THE PISTON DAMAGED THE IOL, PRECLUDING ITS USE. DOCTOR TOOK OTHER IOL IN HIS STOCK AND IMPLANTED IT IN THE PATIENT, WITH NO OCCURRENCES, COMPLETING THE SURGERY. THERE WAS NO PATIENT CONTACT AND EVENT OCCURRED DURING HANDLING PRIOR TO INSERTION. NO FURTHER INFORMATION IS AVAILABLE. Manufacturer Narrative: PATIENT IDENTIFIER, WEIGHT, ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. IMPLANT DATE: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. HENCE, NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. |