BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 13CM DIAPHYSEAL SEGMENT

    MDR report key: 3955018 · Received July 24, 2014

    Report

    Report Number
    0001825034-2014-06431
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    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 4 STATES, "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, AND/OR EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06431/06433).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FRACTURED TAPER. DURING THE PROCEDURE, PATIENT WAS CONVERTED TO A TOTAL FEMUR AS A RESULT OF BONE LOSS AND A COLD WELDED TAPER. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE ON (B)(6) 2011. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO A FRACTURED TAPER. DURING THE PROCEDURE, PATIENT WAS CONVERTED TO A TOTAL FEMUR AS A RESULT OF BONE LOSS AND A COLD WELDED TAPER. A 90 MINUTE DELAY OCCURRED DURING THE PROCEDURE. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE SURGERY DATE AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434688 OSS 13CM DIAPHYSEAL SEGMENT PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 897100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R