BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 50MM

    MDR report key: 1900055 · Received November 9, 2010

    Report

    Report Number
    9616680-2010-00721
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 25, 2005
    Report Date
    October 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "IT WAS REPORTED BY THE PATIENT'S WIFE THAT EVER SINCE PATIENT RECEIVED HIS HIP REPLACEMENT HE HAS BEEN EXPERIENCING EXTREME PAIN AND HAS DEVELOPED SEVERAL MEDICAL CONDITIONS SUCH AS: ANEMIA, DIABETES, HIGH CHOLESTEROL, OSTEOARTHRITIS ETC. THE AREA OF THE PATIENT INCISION HAS AN INDENT IN HIS SKIN BIG ENOUGH TO FIT HIS WIFE'S PALM OF HER HAND IN. WHEN THE PATIENT IS TOUCHED IN THAT AREA IT IS VERY PAINFUL FOR HIM. HE ALSO TAKES PAIN MEDICATION AS NEEDED FOR PAIN AND SOMETIMES HAS TO USE A WALKER TO GET AROUND. THE FAMILY WAS TOLD THAT THE HOSPITAL WHERE THE SURGERY TOOK PLACE HAS BEEN CLOSED DOWN AND NO INFORMATION ON HIS SURGERY CAN BE OBTAINED. THE PATIENT'S WIFE HAS REACHED OUT TO DR. AND HE STATES HE HAS NO MEDICAL RECORDS OF WHAT WAS IMPLANTED IN THE PATIENT AND WAS TOLD TO CONTACT STRYKER AND WE COULD LOOK IT UP. PATIENT'S WIFE STATED THAT IT WAS OK FOR STRYKER TO CONTACT HER SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 50MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 13863201

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R