BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HEAD LATERAL POROUS FEMORAL 9MM

    MDR report key: 3241441 · Received July 22, 2013

    Report

    Report Number
    0001825034-2013-02849
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    April 25, 2005
    Report Date
    June 24, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK003429
    Removal / Correction Number
    N/A
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. INTRAOPERATIVELY, THE FEMUR FRACTURED AND A CERCLAGE CABLE WAS USED IN THE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2005 AND THE CABLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340242 MALLORY-HEAD LATERAL POROUS FEMORAL 9MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 895030

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R