BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM

    MDR report key: 3926121 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02608
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    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. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    ACETABULAR REVISION DUE TO LOOSE CUP.

    Description of Event or Problem · 1

    ACETABULAR REVISION DUE TO LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403056 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMD3Y6

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention