BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 1971715 · Received January 20, 2011

    Report

    Report Number
    9610726-2011-00010
    Event Type
    Other
    Date Received
    January 20, 2011
    Date of Event
    November 21, 2008
    Report Date
    January 5, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT#: REP136. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT'S DAUGHTER, CALLED TO ASK IF HER FATHER'S HIP IMPLANTS WERE PART OF A RECALL AND THAT HER FATHER IS EXPERIENCING DIFFICULTY STANDING AND WALKING AND IS IN PAIN. FEELS LIKE THERE IS SOMETHING WRONG WITH THE IMPLANT ITSELF, LIKE IT IS DISCONNECTED, BREAKING OR LOOSE. PT'S DAUGHTER STATES THAT THE DOCTOR SEES NOTHING WRONG AND SAYS IT MUST BE THE IMPLANT THAT IS GIVING HIM TROUBLE. UPON FURTHER PROBING, IT WAS FOUND THAT APPARENTLY THE PT HAS STRYKER BONE CEMENT AND THAT THE IMPLANT IS A ZIMMER VERSYS HIP SYSTEM. PT'S DAUGHTER IS ASKING IF IT IS POSSIBLE THAT THE BONE CEMENT CRACKED AND THAT IT IS CAUSING THE PROBLEMS WITH THE HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA RAP058

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other