BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 773880 · Received October 25, 2006

    Report

    Report Number
    1825034-2006-00097
    Event Type
    Injury
    Date Received
    October 25, 2006
    Date of Event
    September 26, 2006
    Report Date
    September 27, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    KWA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. REVIEW OF DEVICE HISTORY RECORDS SHOW LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT FILED ON OCTOBER 25, 2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2006. PATIENT DISLOCATED PROSTHESIS AND RETURNED TO SURGERY FOR OPEN REDUCTION TWENTY DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD PROSTHESIS, HIP, COMP. KWA BIOMET, INC. NA 129640

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R