BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL MULTI

    MDR report key: 4123312 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03657
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT PROVIDED, 5982401 IS NOT VALID. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING CUP LOOSENING INVOLVING A TRIDENT HEMISPHERICAL MULTI WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAS BEEN ONE OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION OF LEFT HIP DUE TO A LOOSE CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD REVISION OF LEFT HIP DUE TO A LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602503 TRIDENT HEMISPHERICAL MULTI IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 5982401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R