BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX ARC HIP STEM

    MDR report key: 3568450 · Received January 6, 2014

    Report

    Report Number
    MW5033772
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    February 20, 2012
    Report Date
    January 4, 2014
    Manufacturer
    OMNI LIFE SCIENCE
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012 FOR ADVANCED OSTEOARTHRITIS. THERE WERE NO COMPLICATIONS WITH THE SURGERY AND THE PATIENT DID WELL FOR ELEVEN MONTHS. SHE COMPLAINED OF SWELLING OF THE WHOLE LEFT LOWER EXTREMITY AND A MASS MEDIALLY. AFTER MANY TESTS, A PSEUDO TUMOR CONSISTING OF NECROTIC TISSUE WAS FOUND. SHE UNDERWENT A LAPAROSCOPIC RESECTION OF THE LEFT RETROPERITONEAL TUMOR AND A REVISION LEFT TOTAL HIP ARTHROPLASTY WITH DEBUNKING OF THE PSEUDO TUMOR SEVEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8251 APEX ARC HIP STEM HIP PROSTHESIS, UNCEMENTED LPH OMNI LIFE SCIENCE HC-21003-HA 8629

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R