BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC LAT PC 12X140MM T1

    MDR report key: 6090610 · Received November 9, 2016

    Report

    Report Number
    3002806535-2016-00816
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    August 24, 2015
    Report Date
    October 10, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION IN THE UNITED STATES UNDER 510K NUMBER K030055.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO ASEPTIC, LYMPHOCYTE-DOMINATED VASCULITIS-ASSOCIATED LESION (ALVAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742087 BI-METRIC LAT PC 12X140MM T1 PROSTHESIS, HIP JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R