BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM

    MDR report key: 3881932 · Received June 18, 2014

    Report

    Report Number
    0002249697-2014-02355
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRITANIUM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE ADDITIONAL INFORMATION IS NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT TOTAL HIP REVISED DUE TO DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT TOTAL HIP REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356969 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 48MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLNTKW

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention