BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE CM CEMENTED HIP #4

    MDR report key: 2090893 · Received May 12, 2011

    Report

    Report Number
    9616680-2011-00297
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    July 7, 2010
    Report Date
    April 26, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K936127
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION 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 CALLED TO REPORT THAT HE IS EXPERIENCING PROBLEM WITH HIS HIP IMPLANT. HE BELIEVES THAT IT IS A RELIANCE HIP STEM. HAS PAIN FROM HIS HIP THROUGH TO HIS GROIN. HE HAS TO WALK WITH A WALKER. HIS THIGH IS NUMB AND WHEN HE SITS, AND GETS UP, HE CAN BARELY MOVE. PT SAID THAT HE DID REPORT THIS TO THE FDA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE CM CEMENTED HIP #4 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA 30643405

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other