BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER HIP REPLACEMENT

    MDR report key: 876163 · Received July 2, 2007

    Report

    Report Number
    MW5002920
    Event Type
    Other
    Date Received
    July 2, 2007
    Date of Event
    October 2, 2003
    Report Date
    July 2, 2007
    Product Code
    MRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A STRYKER CERAMIC AND TITANIUM HIP REPLACEMENT AND HAVE HAD IT SINCE 2003, I FIRST NOTICED THE SQUEAK WHILE MAKING LOVE, IT WORSENED: AND GOING UP STAIRS IS ACTUALLY QUITE NOISY. WITH ONE FOOT ON A CHAIR, RAISING MY WEIGHT WITH THE REPLACED HIP, IT SOUNDS LIKE A RUSTY GATE HINGE AND EMITS ABOUT A 2 OCTAVE RANGE. HERE IS THE RESPONSE I GOT FROM STRYKER WHEN I EMAILED THEM ABOUT MY SONOROUS ASTABULARIUM: A FEW PATIENTS WITH CERAMIC-ON-CERAMIC HIPS REPORT THAT IN CERTAIN SITUATIONS, THEY HEAR A NOISE, OR SQUEAKING, EMANATING FROM THE HIP. SURGEONS HAVE ALSO REPORTED ON PATIENTS WHO REPORTED NOISE DURING VERY SPECIFIC ACTIVITIES, SUCH AS RISING FROM A CHAIR OR WALKING UP STAIRS, AND THAT OFTEN THE NOISE WILL DISAPPEAR SPONTANEOUSLY. THE NUMBER OF REPORTS IS LOW IN RELATION TO THE NUMBER OF COMPONENTS. HOWEVER, THE PERCEPTION OF THE NOISE IS A CONCERN BECAUSE IT AFFECTS PATIENTS QUALITY OF LIFE. WHILE STRYKER ORTHOPAEDICS HAS NOT BEEN ABLE TO IDENTIFY THE CAUSE OF THE REPORTED NOISE, WE ARE CONTINUING TO EVALUATE ALL REPORTS AND KEEPING A DIALOGUE WITH CLINICIANS. REGARDS, STRYKER. DATES OF USE: 2003 - 2007. DIAGNOSIS: AVASCULAR NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER HIP REPLACEMENT NONE MRA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other