BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 58MM

    MDR report key: 3120480 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01714
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. 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

    PATIENT HAD THR DONE IN 2005 AND CUP BECAME LOOSE AND SPUN.

    Description of Event or Problem · 1

    PATIENT HAD THR DONE IN 2005 AND CUP BECAME LOOSE AND SPUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222691 TRIDENT HEMISPHERICAL CLUSTER 58MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 12268901

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R