BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DALL MILES CABLE SYSTEM

    MDR report key: 2160861 · Received June 28, 2011

    Report

    Report Number
    2160861
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 27, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PT. RETURNED TO OR POST RIGHT HIP HEMIARTHROPLASTY DUE TO DISPLACED FEM NECK FRACTURE AFTER A ONE WEEK POST OPERATIVE HISTORY OF INCREASING RIGHT HIP PAIN, SWELLING, AND ERYTHEMA WITH MINIMAL DRAINAGE. CT SCAN SHOWED A LARGE POSTERIOR FLUID COLLECTION (8 X 7 CM) POSTERIOR TO HIS PROXIMAL FEMUR. PATIENT FOUND TO HAVE AN INFECTED RIGHT HIP WITH MICROBIAL CULTURE RESULTS POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS(MRSA). SUBSEQUENTLY, AN EXCHANGE OF FEMORAL HEAD COMPONENT, DEBRIDEMENT, AND IRRIGATION OF PERIPROSTHETIC INFECTION WAS PERFORMED. PATIENT RETURNED TO THE OR FOR REMOVAL OF FEMORAL COMPONENT, PLACEMENT OF ARTICULATING ANTIBIOTIC SPACER, DEBRIDEMENT, AND IRRIGATION OF PERIPROSTHETIC INFECTION, WITH IMPLANT OF HEAD: 56 MM -3 NECK AND HIP STEM IN SIZE 4 MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALL MILES CABLE SYSTEM DALL MILES CABLE JDQ STRYKER MEDICAL 6704-0-510 36229606
    2 HIP HEAD 56MM DEPUY HIP HEAD KWY DEPUY 1363-56-000 ZS4C11000
    3 HIP TAPERED SPACER 12-14MM HIP TAPERED SPACER KWY DEPUY 1363-10-000 FB2MG1000
    4 DEPUY FEMORAL PROSTHETIC STEM SIZE 7 TAPERED FEMORAL PROSTHETIC STEM KWY DEPUY 1570-01-135 E1SD81

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R