BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 58MM

    MDR report key: 2120373 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00369
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CUSTOMER CALLED TO STATE HE HAD A HIP REPLACEMENT 2 YEARS AGO. IT HAS ALWAYS BOTHERED HIM. HE IS SCHEDULED TO HAVE A NEW ONE TO REPLACE THE ONE HE CURRENTLY HAS. HE WOULD LIKE TO KNOW IF THERE IS ANY COMPENSATION OR ASSISTANCE SINCE HE NEEDS THIS HIP REPLACED. PLEASE CALL TO FOLLOW UP WITH CUSTOMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 58MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 27639201R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention