BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 5.0X130

    MDR report key: 2992130 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00496
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "THE PATIENT IS TO BE ADVISED OF THE LIMITATION OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED. EXCESSIVE ACTIVITY, TRAUMA, AND/OR WEIGHT GAIN HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR. LOOSENING OF THE IMPLANTS CAN RESULT IN INCREASED PRODUCTION OF WEAR PARTICLES, AS WELL AS ACCELERATE DAMAGE TO BONE MAKING SUCCESSFUL REVISION SURGERY MORE DIFFICULT."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A FRACTURE OF THE FEMUR AT THE LOCATION OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97930 TAPERLOC POR LAT FMRL 5.0X130 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 570750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R