BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS MOD T HANDLE

    MDR report key: 3200895 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02430
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. FUNCTIONAL TESTS WERE PERFORMED AND NO ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION PROCEDURE OF COMPETITOR PRODUCTS, THE TORQUE-LIMITING HANDLE WOULD NOT STAY ENGAGED. AS A RESULT, THERE WAS A DELAY TO THE PROCEDURE OF ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303376 ARCOS MOD T HANDLE PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 419408

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization