BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT

    MDR report key: 5161574 · Received October 13, 2015

    Report

    Report Number
    MW5057152
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    March 27, 2012
    Report Date
    October 5, 2015
    Manufacturer
    DEPUY/ SYNTHES
    Product Code
    HSH
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A KNEE REPLACEMENT THAT WAS A DEFECTIVE FAILURE THAT WARRANTED A TOTAL REVISION RIGHT TOTAL KNEE REPLACEMENT BY DR (B)(6) 2014. AFTER THE REPLACEMENT DIAGNOSED WITH DVT'S IN BOTH LEG-IN BOTH LEGS (B)(6) 2014, CONFINED TO USING A WALKER FOR AMBULATION. RECEIVED A RIGHT KNEE REVISION TIBIAL SPACER EXCHANGE POSSIBLE TIBIA PLATE EXCHANGE. I DISCOVERED ON DATE (B)(6) 2014 BY DR. (B)(6) PERFORMING A REVISION OPERATION IN MY RIGHT KNEE REPLACEMENT OF PAD, TIBIAL SPACER EXCHANGE, THAT DR (B)(6) OPERATION ON DATE (B)(6) 2012 TO MY RIGHT KNEE, CAUSING INJURY TO MY RIGHT KNEE,. I WAS HARMED CAUSING PAIN, AND SUFFERING. I DISCOVERED ON DATE (B)(6) 2014 AT A DR. VISIT TO DR. (B)(6) WHO INFORMED ME THAT I HAD BLOOD CLOT IN MY RIGHT KNEE BEFORE OPERATION ON (B)(6) 2012. DR. (B)(6) WAS NEGLIGENT. I DIDN'T KNOW TO GET TREATMENT FROM DR. (B)(6), I KNOW NOW TO GET TREATMENT FROM DR. (B)(6). I NOW GOT BLOOD CLOT IN BOTH LEGS AND KNEE DUE TO DR. (B)(6) INJURY. I GOT TO GO TO DR (B)(6) FOR ONE YEAR TO GET THE BLOOD CLOTS CORRECTED. (B)(4) IS NAMED IN PRODUCT LIABILITY, THE MANUFACTURER FOR DEFECTIVE PRODUCT, THE KNEE IS DEFECTIVE UNTIL DR. (B)(6) CORRECTED IT. THE (B)(6) HOSPITAL WAS NEGLIGENT, THE HOSPITAL ALLOWED DR. (B)(6) TO PERFORM THE OPERATION, THEY WITHHELD, CONCEALED THE DIAGNOSIS FROM DR. (B)(6) THAT DVT'S IN RIGHT LEG BEFORE THE KNEE REPLACEMENT, PUTTING (B)(6) IN DANGER OF A HEART ATTACK OR A STROKE. WOULDN'T HAVE GONE IF (B)(6) HOSPITAL WOULD NOT HAVE TOLD OF THE DIAGNOSIS OF DVT'S IN LEGS. WOULDN'T HAVE GONE BACK TO DR (B)(6) TO GET TREATMENT FOR THE DVT'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675632 TIBIAL INSERT TIBIAL INSERT HSH DEPUY/ SYNTHES 96-2151 3315274
    675633 TIBIAL TRAY TIBIAL TRAY HSH DEPUY/SYNTHES 129433160 2996074
    675634 PATELLA PATELLA HTG DEPUY/SYNTHES 96-0103 3426426
    675694 CEMENT BONE VISCOSITY CEMENT BONE VISCOSITY LOD DEPUY/SYNTHES 3092040 3307376
    675695 CEMENT BONE VISCOSITY CEMENT BONE VISCOSITY LOD DEPUY/SYNTHES 3092040 3276745
    675696 FEMORAL COMPONENT FEMORAL COMPONENT HSA DEPUY/SYNTHES 1960-50-500 184872

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention