BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS DIAPHYSEAL SEGMENT 17CM W/SCREWS

    MDR report key: 1884327 · Received October 27, 2010

    Report

    Report Number
    1825034-2010-00483
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K002757
    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. 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: IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS AND INSTRUMENTS PRIOR TO PERFORMING SURGERY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ONCOLOGY SALVAGE PROCEDURE ON (B)(6), 2009. SUBSEQUENTLY, IT WAS DETERMINED THAT THE LEG LENGTH WAS TOO LONG AND THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 AND THE DIAPHYSEAL SEGMENT AND MODULAR HEAD WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE ACETABULAR LINER WAS REMOVED AND REPLACED AS WELL; HOWEVER, THE LINER WAS A COMPETITOR'S PRODUCT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSS DIAPHYSEAL SEGMENT 17CM W/SCREWS PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 872840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R