BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ORTHOPAEDICS

    MDR report key: 2341669 · Received November 11, 2011

    Report

    Report Number
    MW5023113
    Event Type
    Injury
    Date Received
    November 11, 2011
    Date of Event
    December 28, 2009
    Report Date
    November 11, 2011
    Manufacturer
    HOWMEDICA OSTEONICS CORP
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD LEFT HIP REPLACEMENT SURGERY (B)(6) 2009, AND I HAVE MORE PAIN NOW THAN BEFORE THE SURGERY. MY PAIN IS IN THE JOINT AREA AND IN THE OUTER THIGH OF THE OPERATED LEG. ON (B)(6)2011, I WORK UP AND STARTED WALKING; HOWEVER, AFTER A FEW STEPS, I FELL TO THE FLOOR IN EXCRUCIATING PAIN LIKE I HAVE NEVER FELT IN MY LIFE; FOR THE NEXT SEVERAL MONTHS I HAD TO GO BACK TO USING A WALKER. I AM NOT USING THE WALKER NOW; HOWEVER, WITH EVERY STEP I STILL HAVE PAIN IN THE JOINT AREA AND IN THE OUTER THIGH; I HAVE DIFFICULTY GOING UP STAIRS AND HAVE TO PULL MYSELF UP. SINCE THE SURGERY I HAVE ALSO DEVELOPED EXTREME LOWER BACK PAIN. I AM LOOKING FOR ANSWERS FOR WHY I CAN NOT RECOVER FROM THE SURGERY; I WAS IN GOOD SHAPE PRIOR TO SURGERY, AS I AM A DANCE INSTRUCTOR. I AM NOW SUSPECTED THE MEDICAL COMPONENTS. THE FOLLOWING STRYKER ORTHOPAEDICS COMPONENTS WERE IMPLANTED IN ME: TRIDENT PSL HA SOLID BLACK ACETABULAR SHELL SIZE 50MM, ALPH CDE E, REF (B)(4), LOT 31557540010022000; SECUR-FIT MAX 127 DEGREE NECK ANGLE HIP STEM SIZE 7, NK LNTH 30MM, TPR C-TPR, REF (B)(4), LOT MHNH8Y, SN (B)(4); TRIDENT X3 0 DEGREE POLYETHYLENE INSERT ID 36MM, ALPH CDE E, REF (B)(4), LOT MHNW35, SN (B)(4); BIOLOX DELTA CERAMIC C-TAPER FEMORAL HEAD OD 36MM, NK LNTH -5MM, REF 18-36-5, LOT SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ORTHOPAEDICS TRIDENT PSL HA SOLID BACK ACETABULAR SHELL LZO HOWMEDICA OSTEONICS CORP 3157501
    2 SECUR-FIT MAX 127 DEGREE NECK ANGLE HIP STEM SIZE 7 HIP STEM LZO HOWMEDICA OSTEONICS CORP MHNH8Y
    3 TRIDENT X3 0 DEGREE POLYETHYLENE INSERT ID 36MM INSERT LZO HOWMEDICA OSTEONICS CORP MHNW35
    4 BIOLOX DELTA CERAMIC C-TAPER FEMORAL HEAD OD 36MM FEMORAL HEAD LZO HOWMEDICA OSTEONICS CORP 30914101

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention| S