BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAP MODULAR TAPERLOC FEMORAL LATERALIZED STEM 9MM X 137MM

    MDR report key: 2062638 · Received April 19, 2011

    Report

    Report Number
    1825034-2011-00285
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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: "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND EXCESSIVE ACTIVITY." THIS REPORT FILED APRIL 19, 2011.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION - THE DESCRIPTION WAS UPDATED TO INCLUDE INFORMATION RECEIVED INDICATING THE STEM REMOVED DURING THE REVISION WAS UNDERSIZED FOR THE PATIENT.THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND DIFFERENT COLORED RESIDUES ON THE POROUS METAL SURFACES. THE NON-POROUS DISTAL STEM IS UNREMARKABLE. THE PROXIMAL TAPER HAS SCRATCHES AND A DENT ON THE TAPER SURFACE WHICH COULD HAVE BEEN FROM IMPLANT REMOVAL. THERE ARE FEW SIGNS OF WEAR THAT MIGHT SUGGEST FRETTING. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO THE STEM LOOSENING. THE STEM WAS REMOVED AND REPLACED AND THE SURGEON NOTED THERE WAS NO INFECTION PRESENT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO THE STEM LOOSENING. THE STEM WAS REMOVED AND REPLACED. IT WAS ADDITIONALLY REPORTED THAT THE STEM SELECTED FOR IMPLANTATION DURING THE INITIAL PROCEDURE ON (B)(6), 2009 WAS NOT THE APPROPRIATE SIZE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAP MODULAR TAPERLOC FEMORAL LATERALIZED STEM 9MM X 137MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 795570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R