BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2091591 · Received May 12, 2011

    Report

    Report Number
    2091591
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 12, 2011
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT TOTAL HIP REVISION TO RIGHT HIP. PT COMPLAINED OF PAIN AND ACHING WHILE WALKING THAT HAS BEEN PERSISTING FOR ABOUT 5 TO 6 MONTHS. SHE CURRENTLY TAKES PERCOCET AND METHADONE FOR THE PAIN. SHE REPORTS BEING ABLE TO WALK ABOUT 15 TO 20 FEET BEFORE HAVING TO SIT DOWN DUE TO THE PAIN. PT AMBULATES WITH A CANE. THERE HAS BEEN NO ASSOCIATED SWELLING/NUMBNESS OR TINGLING.PATIENT ORIGINALLY HAD PERCUTANEOUS PINNING OF A RIGHT FEMORAL NECK FRACTURE SEVERAL YEARS AGO WITH SUBSEQUENT TOTAL HIP ARTHROPLASTY PERFORMED ON PT'S RIGHT HIP. PT PRESENTED FOR SURGERY WITH LONG TERM RIGHT HIP PAIN NOT RELIEVED WITH CONSERVATIVE MEASURES. IMAGING REVIEW OF RIGHT HIP: LOOSENED ACETABULAR COMPONENT OF HIP PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ACETABULAR SHELL KWB HOWMEDICA OSTEONICS CORP. 502-03-52-52 D MHDDMT
    2 TRIDENT ACETABULAR LINER KWB HOWMEDICA OSTEONICS 623-00-36D MHR3EA
    3 * FEMORAL HEAD KWY STRYKER 6570-0-736 30764901
    4 * CANCELLOUS SCREW HWC HOWMEDICA OSTEONICS 2030-6540-1 MHLXYM
    5 CANCELLOUS BONE SCREW SCREW, FIXATION, CANCELLOUS HWC STRYKER 2030-6545-1 MHJ9WY
    6 * CANCELLOUS BONE SCREW HWC STRYKER 2030-6535-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R