BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SELF-TAPPING BONE SCREW

    MDR report key: 1901901 · Received November 17, 2010

    Report

    Report Number
    1825034-2010-00563
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    November 18, 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 DEVICES WERE STERILIZED IN ACCORDANCE WITH ISO 11137-2. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED SUGGESTS THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE DUE TO INFECTION. REVIEW OF INVOICE HISTORY REVEALED THAT PATIENT WITH A HISTORY OF TWO STAGE REVISION UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(), 2009. ALL COMPONENTS WERE REMOVED 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 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 867510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R