BEUDAMED
    FDA Adverse Event Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION S 5

    MDR report key: 3242772 · Received July 18, 2013

    Report

    Report Number
    MW5030974
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ZIMMER
    Product Code
    ---
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR (B)(6) 2013: DUE TO DEGENERATIVE ARTHRITIS IN MY RIGHT KNEE, I REQUIRED A TOTAL KNEE REPLACEMENT ON (B)(6) 2012 AT THE (B)(6) HOSPITAL LOCATED IN (B)(6). I HAD SCHEDULED QUARTERLY F/U APPOINTMENTS WITH THE SURGEON, DR (B)(6), WHO PERFORMED MY REPLACEMENT. THESE APPOINTMENTS WERE FROM (B)(6) 2012 TO (B)(6) 2013. DURING THIS TIME PERIOD, I SUFFERED WITH CHRONIC JOINT PAIN AND DISCOMFORT IN MY RIGHT KNEE, DIFFICULTY AND PAIN WHEN WALKING, INABILITY TO STAND OR WALK FOR LONG PERIODS OF TIME, SWELLING IN THE KNEE, POPPING OR CRUNCHING SOUNDS IN THE KNEE WHEN WALKING OR BENDING, WEAKNESS OR "GIVING" IN THE KNEE WHEN WALKING, LIMITING MOBILITY, PAIN AND DISCOMFORT IN MY RIGHT HIP AND LOWER SIDE OF MY BACK DUE TO COMPENSATION IN WALKING AND STANDING DUE TO THE PAIN IN MY RIGHT KNEE, PAIN AND DISCOMFORT IN MY RIGHT KNEE AND HIP WHEN I STAND FROM A SITTING POSITION, AND NOW, LOOSENING OF THE KNEE REPLACEMENT. THE FOLLOWING EVENT DETAIL MY POST SURGERY. UPON MY QUARTERLY CHECK-UPS I WOULD INQUIRE WITH DR (B)(6) AS TO WHY I WAS HAVING THE BEFORE MENTIONED SYMPTOMS. HE COULD NOT PROVIDE A REASON OR EXPLANATION, BUT ALWAYS HAD AN X-RAY TAKEN TO INSPECT. HE ALWAYS HAD THE SAME COMMENT, THAT EVERYTHING LOOKED "GREAT OR BEAUTIFUL." ON MY ONE YR VISIT ((B)(6) 2013) IT WAS THE SAME ROUTINE, ONLY THIS TIME HE SAID "I'LL SEE YOU IN A YR!" I COULDN'T BELIEVE MY EARS. I STILL HAD ALL THE SAME SYMPTOMS AND CHRONIC PAIN THAT I HAD EXPERIENCED FROM TWELVE MONTHS. I DECIDED TO DO SOME RESEARCH. I CHECKING THE INTERNET I FOUND THAT THE ZIMMER NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS) FEMORAL COMPONENT OPTION MODEL REPLACEMENT (THE SAME KNEE THAT I HAD INSTALLED) HAD BEEN RECALLED BY THE FDA. THE MFR, ZIMMER, HAD SENT OUT LETTERS IN SEPTEMBER 2010 TO SURGEONS ADVISING THEM OF THE RECALL, BUT ACTION WAS REQUIRED; AND AGAIN IN DECEMBER 2010 WITH VOLUNTARY RECALL TO URGENTLY REMOVE THE KNEE IMPLANT DEVICES AND RETURN THE NEXGEN COMPLETE KNEE SOLUTION LPS FLEX GENDER FEMORAL COMPONENTS TO THE MANUFACTURES. I ALSO FOUND NUMEROUS PAGES CONCERNING CLASS ACTION LAWSUITS THAT WERE CONSOLIDATED IN THE US DISTRICT COURT OF (B)(4) UNDER THE MULTIDISTRICT LITIGATION (MDL CASE (B)(4)) ABOUT THE PROSTHESIS FAILURE AND REVISION SURGERY. DR (B)(6) NEVER MENTIONED THE FDA RECALL OR THE CLASS ACTION LAWSUITS TO ME PRIOR TO OR AFTER MY SURGERY. I VISITED DR (B)(6) AGAIN ON (B)(6) 2013 DUE TO PAIN AND THE OTHER SYMPTOMS. AGAIN HE TOOK ANOTHER X-RAY AND I REC'D THE SAME EXPLANATION AS BEFORE. I ASKED HIM IF ZIMMER WAS THE ONLY BRAND OF KNEE REPLACEMENT DEVICE THAT HE USED AND HE SAID YES AND THAT HE STANDS BEHIND IT 100%. I THEN MENTIONED THE RESEARCH THAT I HAD DONE AND MENTIONED THE RECALL AND CLASS ACTION LAWSUITS TO WHICH HE STATED "PROFANITY." AFTER SOME MORE CONVERSATION, HE ASKED IF I WOULD LIKE TO GET A SECOND OPINION. I HESITATED FOR A MOMENT AND BEFORE I COULD ANSWER HE INSISTED THAT I GET ONE, FOR "PEACE OF MIND" AND JUST TO MAKE SURE HE DIDN'T MISS SOMETHING. HE OFFERED TO SET IT UP SO I AGREED. WHEN I STOPPED AT THE FRONT DESK ON MY WAY OUT, I WAS TOTALLY SURPRISED TO FIND OUT THAT HE HAD ACTUALLY REQUESTED TO SET ME UP TO MEET WITH A COLLEAGUE IN THE SAME OFFICE AS HIS. ON THURSDAY, (B)(6) 2013, I MET WITH DR (B)(6) OF (B)(6) TO DISCUSS PAIN AND COMPLICATIONS THAT I HAD BEEN EXPERIENCING WITH MY KNEE FOR OVER A YEAR. HE REVIEWED X-RAYS OF MY TOTAL KNEE REPLACEMENT THAT WAS PERFORMED BY DR (B)(6), A PRINCIPLE WITH DFP ORTHOPEDIC SURGERY ON (B)(6) 2012. UPON REVIEW OF THE X-RAYS THAT WERE TRANSFERRED FROM DR (B)(6) OFFICE, DR (B)(6) DISCOVERED A CRACK IN MY TIBIAL BONE FROM THE LOWER PORTION OF THE ZIMMER NEXGEN (TKR) MODEL THAT WAS INSTALLED IN MY KNEE. THIS CRACK WAS FOUND IN ALL X-RAYS THAT WERE TAKEN AT THE TIME OF MY 3-MONTH, 6-MONTH, 9-MONTH, ANNUAL, AND SUBSEQUENT (B)(6), 2013 VISIT THAT I REQUESTED DUE TO PERSISTENT PAIN AND DISCOMFORT SINCE THE TKR. DR ORTH THEN SCHEDULED A BONE SCAN AT (B)(6) HOSPITAL FOR TUESDAY, (B)(6) 2013 TO DETERMINE IF AN INFECTION MIGHT BE IN MY PROSTHESIS. I THEN MET WITH DR (B)(6) ON THURSDAY, (B)(6) 2013 TO DISCUSS THE RESULTS WHICH DID NOT REVEAL AN INFECTION. AFTER SOME DISCUSSION, HE DECIDED IT WOULD BE BEST TO HAVE A TOTAL JOINT SUBTRACTION CT SCAN ON MY RIGHT KNEE TO REMOVE THE TOTAL KNEE PROSTHESIS TO GET A BETTER VISUALIZATION OF WHAT WE WERE DEALING WITH. I MET WITH DR (B)(6) ON THURSDAY, (B)(6) 2013 TO REVIEW THE RESULTS. THE CT SCAN CONFIRMED A CRACK OR FRACTURE IN THE MEDIAL TIBIAL METAPHYSEAL REGION IN AS WELL AS THE SEPARATION (BETWEEN THE CEMENT INTERFACE AND THE BONE ITSELF ACROSS THE MEDIAL AND POSTERIOR ASPECT MEDIALLY OF THE SURGICAL KNEE REGION). THIS SEPARATION APPEARS IDENTICAL TO THE TYPE OF SEPARATION FOUND IN THE ZIMMER KNEE LAWSUIT MULTIDISTRICT LITIGATION (MDL NO. (B)(4)). AFTER THE DISCOVERY OF THIS INFO, I TOOK IT UPON MYSELF TO SEEK THE COUNSEL OF A RADIOLOGIST, DR (B)(6), AND HE TOO VALIDATED THE SAME FINDINGS AS DR (B)(6). I HAVE INCLUDED A DISC OF THE X-RAYS TAKEN BY THE STAFF OF DR (B)(6) FOR YOUR REVIEW. I'M CONFIDENT YOU WILL BE ABLE TO SEE THE CRACK OR FRACTURE, IN AS WELL AS, THE SEPARATION NOTED ABOVE BY DR (B)(6). PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS.

    Description of Event or Problem · 1

    AFTER NOT GAINING AN EXPLANATION AS TO ALL MY PAIN AND NUMEROUS OTHER SYMPTOMS FROM THE SURGEON THAT PERFORMED MY TKR SURGERY, I CONTACTED ANOTHER SURGEON TO REVIEW MY X-RAYS FROM THE PREVIOUS SURGEON. HE FOUND A CRACK OR FRACTURE IN MY RIGHT IN THE MEDIAL TIBIAL METAPHYSEAL REGION. MY NEW PHYSICIAN DECIDED TO HAVE A BONE SCAN AND A TOTAL JOINT SUBTRACTION AND THESE TESTS CONFIRMED THE CRACK OR FRACTURE, IN AS WELL AS, A SEPARATION BETWEEN THE CEMENT INTERFACE AND THE BONE ITSELF ACROSS THE MEDIAL AND POSTERIOR ASPECT MEDIALLY OF THE SURGICAL KNEE REGION. I AM AWARE OF THE ZIMMER NEXGEN COMPLETE KNEE SOLUTION CLASS ACTION LAWSUIT ((B)(4)), WHICH I DO NOT BELIEVE MY REPLACEMENT KNEE QUALIFIES, BUT ALL MY SYMPTOMS CHRONIC JOINT AND DISCOMFORT IN MY RIGHT KNEE, DIFFICULTY AND PAIN WHEN WALKING, INABILITY TO STAND OR WALK FOR LONG PERIODS OF TIME, SWELLING IN THE KNEE, POPPING OR CRUNCHING SOUNDS IN THE KNEE WHEN WALKING AND BENDING, WEAKNESS OR GIVING IN THE KNEE WHEN WALKING, LIMITED MOBILITY, PAIN AND DISCOMFORT IN MY RIGHT HIP AND LOWER RIGHT SIDE OF MY BACK DUE TO COMPENSATION IN WALKING AND STANDING DUE TO THE PAIN IN MY RIGHT KNEE, PAIN AND DISCOMFORT IN MY RIGHT KNEE AND HIP WHEN I STAND FROM A SITTING POSITION, AND NOW, LOOSENING OF THE KNEE REPLACEMENT ARE ALL THE SAME AS THOSE NOTED BY THE PTS WHO EXPERIENCED NEXGEN KNEE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335243 NEXGEN COMPLETE KNEE SOLUTION S 5 TIBIAL COMPONENT --- ZIMMER 61941657
    335291 PALACOS R RADIOPAQUE BONE CEMENT BONE CEMENT JWH ZIMMER 72544281
    335292 PALACOS R RADIOPAQUE BONE CEMENT BONE CEMENT JWH ZIMMER 73554282
    335293 NEXGEN COMPLETE KNEE SOLUTION S 38 POLY PATELLA --- ZIMMER 61618535

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention| S BUTRANS PATCH 20MCG/HR| RAPAFLO 8MG| LANSOPRAZOLE 30MG| CYMBALTA 60MG| HYDROCODONE-ACETAMINOPHEN 10-325| METOPROLOL 25MG