BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC HA/PC 13X145MM (T1)

    MDR report key: 3901310 · Received June 30, 2014

    Report

    Report Number
    3002806535-2014-00162
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL TOTAL HIP REPLACEMENT ON (B)(6), 2008. SUBSEQUENTLY, A REVISION PROCEDURE OF THE RIGHT HIP WAS PERFORMED ON AN UNKNOWN DATE DUE TO STEM FRACTURE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381252 BI-METRIC HA/PC 13X145MM (T1) PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 1359955

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R