BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL CUP/CLUSTER SHELL 50MM

    MDR report key: 1973876 · Received January 19, 2011

    Report

    Report Number
    2249697-2011-00035
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    July 31, 2003
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K942900
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "IMMEDIATELY AFTER SURGERY, PT BEGAN EXPERIENCING TROUBLE, FEELS PAIN. HAS A DROP FOOT AFTER THE SURGERY. PT COULD NOT EVEN WALK AFTER THE SURGERY AND WAS EXPERIENCING TERRIBLE PAIN IN THE ANKLE AREA. PT HAS BEEN TOLD THAT THE CUP IS LOOSENING. FEELS NUMBNESS LIKE IT IS ASLEEP. PT HAS GONE THROUGH EXTENSIVE PHYSICAL THERAPY, AT REHAB AND AT HOME. THIS IS SEVEN YEARS LATER, AND SHE IS STILL EXPERIENCING PAIN, AND IS ON PAIN MEDICATION, TERRIBLE LEG AND GROIN PAIN, FEELS MUSCLE SPASMS AND NUMBNESS, ALSO CONTINUES TO FEEL ANKLE PAIN. SEEING DR AND THEY ARE DISCUSSING HER OPTIONS, INCLUDING POSSIBLE REVISION SURGERY. HAS NERVE DAMAGE AND NECROSIS FEMUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIT HA PSL CUP/CLUSTER SHELL 50MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 2N3091

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R