BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2821530 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-02040
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    November 10, 2010
    Report Date
    October 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT IS REPORTING THAT OUTSIDE OF THE HIP JOINT IS HOT AND TENDER. PT IS ALSO REPORTING PERIODS OF SORENESS AND ALSO THAT HER LEG GAVE OUT A COUPLE OF TIMES. PT IS ALSO REPORTING THAT SHE DOES NOT HAVE A SMOOTH MOTION WHEN BENDING OVER AND THAT SHE IS HAVING BALANCE ISSUES. THE PAIN STARTED WITHIN THE LAST SIX MONTHS. BLOOD WORK WAS DONE FOR THE CHROMIUM AND COBALT TESTING THE WEEK OF (B)(6) AND THE RESULTS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LEFT HIP IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other