BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 52MM

    MDR report key: 3023908 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01124
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4): DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT INVOLVING A TRIDENT HEMISPHERICAL CLUSTER 52MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS EVALUATION NOT PERFORMED BECAUSE NO INFORMATION WAS RECEIVED. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE WAS ONE OTHER REPORTED EVENT FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED, ADDITIONAL INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REP RECEIVED AN EMAIL STATING THAT THE SURGEON INDICATED THAT THE PATIENT IS HAVING A NUMBER OF PROBLEMS AND MAY REQUIRE A REVISION. THE SURGEON THOUGHT THERE WAS A RECALL AT SOME POINT ON THESE COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REP RECEIVED AN EMAIL STATING THAT THE SURGEON INDICATED THAT THE PATIENT IS HAVING A NUMBER OF PROBLEMS AND MAY REQUIRE A REVISION. THE SURGEON THOUGHT THERE WAS A RECALL AT SOME POINT ON THESE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125342 TRIDENT HEMISPHERICAL CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 15721901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other