BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM +8 LFIT V40 HEAD

    MDR report key: 3911505 · Received July 3, 2014

    Report

    Report Number
    0002249697-2014-02536
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K010757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING APPEARANCE INVOLVING A METAL HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: DISCOLOURATION WAS OBSERVED ON THE RETURNED HEAD. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSION: NC WAS ISSUED FOR DISCOLORATION OF FEMORAL HEAD.

    Description of Event or Problem · 1

    UPON OPENING THE 32MM+8MM LFIT V40 HEAD IT APPEARED TO BE DISCOLOURED COMPARED TO WHAT IT WOULD NORMALLY LOOK. IT APPEARED A 'SMOKEY GOLDEN' COLOUR.

    Description of Event or Problem · 1

    UPON OPENING THE 32MM+8MM LFIT V40 HEAD IT APPEARED TO BE DISCOLOURED COMPARED TO WHAT IT WOULD NORMALLY LOOK. IT APPEARED A 'SMOKEY GOLDEN' COLOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389418 32MM +8 LFIT V40 HEAD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 35599702

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other