BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMI CUP

    MDR report key: 1915776 · Received November 29, 2010

    Report

    Report Number
    9616680-2010-00773
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. INFO 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, "PT FEELS PAIN AND DISCOMFORT CONSTANTLY IN HIS LEFT HIP. HE MUST USE A CANE AND HIS HIP IS SORE ALL DAY EVERYDAY. HIS HIP HAS BEEN LIKE THIS SINCE THE SURGERY AND IT HAS NEVER GOTTEN BETTER. HE IS CONCERNED THAT HIS HIP WAS PART OF THE RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMI CUP IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other