BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 8X120

    MDR report key: 3941207 · Received July 17, 2014

    Report

    Report Number
    0001825034-2014-06260
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    December 28, 2007
    Report Date
    June 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2007 DUE TO AN UNKNOWN REASON. THE MODULAR HEAD AND FEMORAL STEM WERE REMOVED AND REPLACED. SUBSEQUENTLY, A FURTHER REVISION PROCEDURE HAS BEEN INDICATED DUE TO AN UNKNOWN REASON; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418997 BI-METRIC/X POR NC 8X120 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 271040

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R