BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2831103 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02141
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 12, 2011
    Report Date
    October 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS REPORTING THAT HER HIP STARTED HAVING PAIN A MONTH AND A HALF AGO. PT IS EXPERIENCING PAIN WHEN SHE TWISTS OR TURNS. PT IS ALSO REPORTING THAT SHE IS EXPERIENCING A SHARP PAIN WHEN SHE STANDS UP. PT IS EXPERIENCING DIFFICULTY GOING UP AND DOWN STAIRS. PT STATES THAT SHE CANNOT SLEEP ON THE LEFT SIDE OF HER HIP. SHE IS ALSO STATING THAT SHE IS RESTRICTED IN HER EXERCISE AND IS COMPLAINING OF INFLAMMATION IN HER LEFT HIP AND ALSO BOTH HER ANKLES. PT IS REPORTING THAT WHEN DRIVING SHE HAS TO USE A CUSHION BECAUSE THE SEATING CAUSES PAIN AND DISCOMFORT. SHE IS COMPLAINING OF MORE STRAIN ON HER HIP WITHIN THE LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MKA3TL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other