BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SELF TAPPING SCREW 6.5MM X 50MM

    MDR report key: 1863298 · Received October 9, 2010

    Report

    Report Number
    1825034-2010-00416
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K991807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE SCREWS WERE IMPLANTED AND REMOVED. IT IS NOT KNOWN WHICH SCREW WAS TOO LONG. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: WARNING - CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. POSSIBLE ADVERSE EFFECT - PAIN, DISCOMFORT, OR ABNORMAL SENSATION DUE TO THE PRESENCE OF THE DEVICE. THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN DUE TO A SCREW THAT WAS TOO LONG. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010, AND ALL COMPONENTS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE SELF TAPPING SCREW 6.5MM X 50MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 057760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R