BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE REAMER

    MDR report key: 1080784 · Received July 15, 2008

    Report

    Report Number
    1825034-2008-00193
    Event Type
    Injury
    Date Received
    July 15, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BIOMET, INC
    Product Code
    HTO
    PMA / PMN Number
    exempt
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL HIP ARTHROPLASTY PROCEDURE IN 2008. DURING THE PROCEDURE, THE FLEXIBLE REAMER BROKE APART AT THE PROXIMAL CONNECTOR HEAD TO THE SHAFT. RADIOGRAPHS CONFIRMED THAT PT RETAINED FRACTURED PORTION OF THE REAMER IN THE FEMORAL SHAFT DISTAL TO THE IMPLANTED FEMORAL ROD COMPONENT OF THE TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE REAMER HTO HTO BIOMET, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability