BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SELF-TAPPING BONE SCREW 6.5MM X 30MM

    MDR report key: 1904644 · Received November 22, 2010

    Report

    Report Number
    1825034-2010-00583
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    July 16, 2009
    Report Date
    October 19, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K991807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS THAT DEVICES WERE STERILIZED IN ACCORDANCE WITH (B)(4) . THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    INFORMATION RECEIVED SUGGESTS THAT PATIENT UNDERWENT A REVISION HIP ARTHROPLASTY DUE TO WEAR, OSTEOLYSIS, LOOSE ACETABULAR CUP AND INFECTION. REVIEW OF INVOICE HISTORY REVEALED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND A REVISION HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2009 TO EXCHANGE THE MODULAR HEAD FOR AN UNKNOWN REASON. SUBSEQUENTLY, PATIENT WAS REVISED AGAIN ON (B)(6) 2009. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE SELF-TAPPING BONE SCREW 6.5MM X 30MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 528120

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R