BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMA HIP

    MDR report key: 2549071 · Received April 18, 2012

    Report

    Report Number
    1644408-2012-00205
    Event Type
    Other
    Date Received
    April 18, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 9, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ABOUT TWO WEEKS AFTER SURGERY, THE PT FELL CAUSING THE HIP TO DISLOCATE. AN ATTEMPT TO DO A CLOSED REDUCTION OF THE HIP WAS DONE, WITHOUT PROPER PLACEMENT, SO ANOTHER REVISION SURGERY WAS DONE ON MONDAY, (B)(6). THE DOCTOR REMOVED THE 52MM ACETABULAR SHELL, THE TWO SCREWS, THE HXL ACETABULAR LINER, COCR HEAD, OFFSET SLEEVE, AND STANDARD OFFSET LIMA REVISION PROXIMAL BODY TO GAIN STABILITY. HE IMPLANTED STRYKER ACETABULAR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMA HIP REVISION BODY, STANDARD KWZ ENCORE MEDICAL, L.P. 1101774

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 430-98-052, LOT 58761001| 010-55-015, LOT 003A1020| 411-00-035, LOT 903B1048| 931-36-252, LOT 690F1043| 497-36-000, LOT 638C1037| 010-55-030, LOT 54014677