BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS DIAPHYSEAL SEGMENT 7CM WITH SCREWS POROUS COATED

    MDR report key: 2698440 · Received August 15, 2012

    Report

    Report Number
    0001825034-2012-01297
    Event Type
    Injury
    Date Received
    August 15, 2012
    Date of Event
    August 13, 2012
    Report Date
    July 19, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT IMPLANT FRACTURED DUE TO FATIGUE. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01297-1 / 01298-1).

    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. 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, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01298).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT JOINT RECONSTRUCTION PROCEDURE ON (B)(6), 2009. SUBSEQUENTLY, PATIENT UNDERWENT REVISION ON (B)(6), 2012 DUE TO FRACTURE OF THE TAPER OF THE FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSS DIAPHYSEAL SEGMENT 7CM WITH SCREWS POROUS COATED PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 046960

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R