BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC LAT 9X125

    MDR report key: 2464861 · Received February 22, 2012

    Report

    Report Number
    0001825034-2012-00163
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    May 4, 2009
    Report Date
    January 27, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMET RECEIVED THIS INFORMATION OF THE EVENT THROUGH A MAUDE EVENT REPORT REFERENCE NUMBER (B)(4). 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.THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.THIS IS MDR ONE OF TWO (1825034-2012-00163 AND 1825034-2012-00164) FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE NEW MAUDE EVENT REPORT #(B)(4) WHICH WAS RECEIVED AT BIOMET ON (B)(6), 2012. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00164-1).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS DUPLICATED IN ERROR. NEW INFORMATION WAS RECEIVED AND REPORTED ON MEDWATCH NUMBERS 1825034-2013-00506, 00506-1, 01611/1613. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-0163-2 / 00164-2).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6), 2009. SUBSEQUENTLY, THE PATIENT REPORTS PAIN, BALANCE ISSUES, HIGH LEVELS OF COBALT AND TITANIUM IN HER BLOOD, A MRI SCAN SHOWING ABNORMAL AMOUNT OF FLUID OUTSIDE THE JOINT, AND DETERIORATION AROUND THE SOCKET. PATIENT REPORTS NEED FOR A REVISION SURGERY. BIOMET RECEIVED THIS INFORMATION THROUGH A MAUDE EVENT REPORT REFERENCE NUMBER (B)(4). THIS REPORT IS BASED UPON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE CURRENTLY UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BI-METRIC/X POR NC LAT 9X125 BI-METRIC/X POR NC LAT 9X125 LPH BIOMET ORTHOPEDICS N/A 260220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R