BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 2021742 · Received March 14, 2011

    Report

    Report Number
    MW5019813
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    August 26, 2009
    Report Date
    March 7, 2011
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER (B)(6) 2011: THIS IS A FOLLOW UP TO THE REPORT THAT I MADE EARLIER THIS YEAR CONCERNING THE PROBLEMS THAT I WAS EXPERIENCING AFTER THE COMPLETE KNEE REPLACEMENT PROCEDURE ON MY RIGHT KNEE. THE INSTRUMENT WAS MADE BY DEPUY. IF YOU RECALL, I DESCRIBED THE PROBLEMS THAT I WAS HAVING, STARTING ABOUT THE SECOND WEEK AFTER SURGERY. I COMPLAINED TO ALL INVOLVED WITH MY CARE, HOME-HEALTH CARE, DOCTORS, NURSES, THERAPIST, AND FAMILY MEMBERS. I AM STILL COMPLAINING BECAUSE I AM STILL HAVING PROBLEMS, MAJOR PROBLEMS. SINCE MY FIRST REPORT, I HAVE HAD NEAR-MISSES WITH FALLING, BUT I WANT TO INFORM YOU OF THE TWO FALLS THAT I DID HAVE. ON (B)(6), I WAS WALKING ACROSS THE FLOOR OF MY FAMILY ROOM. THE KNEE LOCKED AS I WAS GOING FORWARD. LUCKILY, I FELL INTO THE RECLINER, WITH MY HEAD EMBEDDING BETWEEN THE BACK OF THE CHAIR AND THE LEFT ARM REST. I CALLED FOR HELP BECAUSE I COULD NOT PUSH MYSELF UP. FOR DAYS, MY NECK, SHOULDERS AND BACK WERE VERY SORE. I USED HEATING PADS AND PAIN PILLS TO FEEL BETTER. THE SECOND FALL WAS A DOOZIE. ON THE EVENING OF (B)(6) 2011, BETWEEN 7:30 AND 8:00 P.M., I WAS ON THE PARKING LOT OF A LOCAL GROCERY STORE. ON MY WAY BACK TO MY TRUCK, AFTER PUTTING THE CART AWAY, AS I LIFTED MY RIGHT FOOT TO GO FORWARD, I FELT THE KNEE LOCK. MY FORWARD MOMENTUM TOOK ME TO THE GROUND. THERE WAS NOTHING I COULD DO TO STOP THE FALL. PEOPLE IN THE PARKING LOT CAME TO MY AID. I WAS BLEEDING BADLY FROM MY FOREHEAD, AND MY LEFT ARM WAS SWOLLEN AND ACHING. I WAS TAKEN TO THE EMERGENCY ROOM OF A NEAR-BY HOSPITAL. X-RAYS OF MY SWOLLEN RIGHT WRIST REVEALED THAT IT WAS BROKEN. I ALSO REQUIRED STITCHES TO CLOSE THE GASH ON THE RIGHT SIDE OF MY FOREHEAD. THERE WERE ALSO OTHER BRUISES. THE EMERGENCY ROOM DOCTOR APPLIED A TEMPORARY CAST IN MY RIGHT WRIST AND PRESCRIBED PAIN PILLS. THE FOLLOWING THURSDAY WHEN I WENT TO A BONE SPECIALIST, A PERMANENT CAST WAS APPLIED. I ALSO TOLD THE DOCTOR OF THE EXTREME CHEST PAINS THAT I EXPERIENCED WHEN I MADE CERTAIN MOVES, SNEEZED, COUGHED, OR TOOK A DEEP BREATH. IT ALSO HURT IF I APPLIED PRESSURE DURING A BOWEL MOVEMENT. HE TOLD ME THAT MY RIBS HAD BEEN INJURED. HE SAID THAT THEY WOULD HEAL WITH TIME. IN THE MEANTIME, I SHOULD TRY SLEEPING IN A RECLINER WHICH WOULD LIMIT MY MOVEMENT. I APPLY HEAT TO EVERYTHING THAT IS SORE, AND TAKE PRESCRIBED PAIN MEDICATIONS. EVEN MY RIGHT KNEE IS SORE AND SWOLLEN WITH A CONSIDERABLE AMOUNT OF NUMBNESS INSIDE MY RIGHT LEG FROM MID-CALF TO MID-THIGH. I HAVE AN APPOINTMENT TO HAVE X-RAYS DONE ON THE RIGHT KNEE ON (B)(6). AS A RESULT OF THE FALL, I AM VERY LIMITED TO THE THINGS THAT I CAN DO, NO WORKING IN MY FLOWER GARDEN, NO DRIVING, NO COOKING, AND VERY LITTLE HOUSE WORK CHORES. I NEED HELP DOING MY HAIR, TAKING A SHOWER, AND GETTING DRESSED. EVEN WORSE, I CANNOT FULLY ENJOY INTIMATE MOMENTS. THE BOTTOM LINE IS THAT I HAVE HAD MANY PROBLEMS WHICH I BELIEVE ARE CAUSED BY THE MALFUNCTIONS OF THE DEPUY INSTRUMENT WHICH WAS PLACED DURING THE PROCEDURE ON (B)(6) 2009. I HAVE COMPLAINED AND MADE IT KNOWN FROM THE START. THIS IS NOT A "JUMP ON THE BANDWAGON" TACTIC. THIS WAS HAPPENING EVEN BEFORE ANY PUBLICATIONS OF A RECALL. PLEASE INFORM ME IF I NEED TO SUBMIT MORE PERSONAL OR MEDICAL INFORMATION. THANK YOU VERY MUCH.

    Description of Event or Problem · 1

    I HAD A TOTAL KNEE REPLACEMENT ON MY RIGHT KNEE USING THE DEPUY DEVICE. WITHIN TWO WEEKS OF THE SURGERY, I STARTED EXPERIENCING AND COMPLAINING ABOUT A "GRABBING" OR "LOCKING" FEELING OF THE DEVICE. I EVEN ASKED MY HOME HEALTH NURSE AND LATER, THE SURGEON, IF THE DEVICE MOVED. SOMETIMES WHEN I DID SOME OF THE REQUIRED EXERCISES, AT HOME OR IN OUTPATIENT THERAPY. I EXPERIENCED THE "LOCKING" OF THE DEVICE. OF COURSE, I WAS TOLD THAT IT DOES NOT MOVE. FOR OVER 18 MONTHS NOW, I HAVE COMPLAINED ABOUT THE PROBLEMS THAT I HAVE BEEN AND AM STILL EXPERIENCING. I HAVE TOLD THE DOCTORS ABOUT THE LOCKING, NUMBNESS IN INNER THIGH AND LEGS, PAIN AND SWELLING. I HAVE ALSO TOLD THEM HOW THE DEVICE LOCKS SOMETIMES WHEN MY KNEE IS EITHER BENT OR WHEN MY LEG IS STRAIGHT. WHEN MY LEG IS STRAIGHT AND IT LOCKS, I HAVE TO SLIDE MY FEET WHEN I WALK. THERE ARE TIMES WHEN IT CATCHES ME BY SURPRISE AND I LOSE MY BALANCE, ALMOST FALLING. I STILL WALK WITH A CANE TO BE ON THE SAFE SIDE. I COMPLAINED TO MY RHEUMATOLOGIST IN (B)(6) 2010, WHO FELT THAT IT WAS THE PROBLEM WITH THE KNEE AND NOT MY BACK AS THE SURGEON HAD SUGGEST AND SENT ME TO THERAPY FOR. THIS WAS DONE AFTER A NERVE CONDUCT TEST RESULTS SHOWED NO PROBLEM WITH MY NERVES. ON (B)(6), I DISCUSSED THE PROBLEM WITH MY PRIMARY CARE PROVIDER. HE COULD NOT EXPLAIN THE LOCKING AND SAID THAT HE WOULD TALK TO THE SURGEON. I AM IN CONSTANT DISCOMFORT. THE SURGEON ONLY TAKES X-RAYS WHICH SHOW THE DEVICE IN THE CORRECT POSITON. HE GIVES ME PAIN PILLS AND SHOTS. THERE IS STILL NUMBNESS (SOMETIMES MILD, OTHER TIMES EXTREMELY STRONG) SORENESS, SWELLING (FROM NOTICEABLE TO THE TOUCH TO VERY VISIBLE.) NOTHING IS BEING DONE TO ELIMINATE THE PROBLEM THAT I THINK IS CAUSED BY THE DEVICE. BY THE WAY, I HAD A SECOND COMPLETE KNEE REPLACEMENT DONE ON MY LEFT KNEE ON (B)(6) 2010. NO PROBLEMS! NO LOCKING OR GRABBING, NO NUMBNESS, ONLY THE SLIGHT SORENESS AND SELDOM SWELLING THAT IS EXPECTED DURING THE FIRST YEAR. THE LEFT KNEE IS DOING WELL. SOMETIMES THERE IS A SHOOTING PAIN FROM MY RIGHT KNEE BOTH DOWN AND UP THE INNER SIDES OF MY THIGH AND LEG. I HAVE AN APPOINTMENT WITH THE SURGEON NEXT MONTH. IT IS FOR THE CHECK UP ON THE SECOND KNEE, BUT I STILL HAVE BIG COMPLAINTS ABOUT MY RIGHT KNEE REPLACEMENT OF (B)(6) 2009. BASED ON THE RESPONSE FROM THE DOCTOR, HE HAS NO VALID EXPLANATION AS TO WHY I AM EXPERIENCING THESE CONSTANT PROBLEMS WITH MY RIGHT KNEE. AS I WRITE THIS, I AM EXPERIENCING LOCKING OF THE DEVICE. IT IS IN THE BENT POSITION. IT HURTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY KNEE REPLACEMENT DEVICE JWH JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other