BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 13X200MM CYL DIST

    MDR report key: 4191948 · Received October 22, 2014

    Report

    Report Number
    0001825034-2014-08249
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO THE STEM SUBSIDING. THE SURGEON BELIEVES THIS WAS CAUSED BY THE STEM BEING UNDERSIZED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672865 ARCOS 13X200MM CYL DIST PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 998720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R