BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD PRESS FIT FEMORAL STEM POROUS COATED SZ 11X160MM

    MDR report key: 6173185 · Received December 14, 2016

    Report

    Report Number
    3002806535-2016-00897
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 10, 2016
    Report Date
    May 16, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF PHOTOGRAPHS OF THE EXPLANTED FEMORAL STEM. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DHR REVIEW WAS PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). IMPLANT DATE - 6 YEARS AGO. THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K030055.

    Description of Event or Problem · 1

    PATIENT WAS REVISED APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO PAIN AND FEMORAL STEM FRACTURE. DURING THE REVISION PROCEDURE, THERE WAS DIFFICULTY REMOVING THE PORTION OF THE STEM INSIDE THE FEMUR. THE FRACTURED PORTION WAS REMOVED AFTER A 1-2 HOUR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823849 MALLORY-HEAD PRESS FIT FEMORAL STEM POROUS COATED SZ 11X160MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 1816583

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R