BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SRRS PRESSED FIT REVISION STEM

    MDR report key: 368622 · Received December 21, 2001

    Report

    Report Number
    2530191-2001-00003
    Event Type
    Malfunction
    Date Received
    December 21, 2001
    Date of Event
    November 30, 2001
    Report Date
    December 21, 2001
    Manufacturer
    STELKAST CO.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED A NON-HEALED TROCHANTER FRACTURE LEAVING THE STEM DISTALLY SUPPORTED WITHOUT PROXIMAL FIXATION. THE STEM FRACTURED AT THE MID-POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58297 SRRS PRESSED FIT REVISION STEM HIP / FEMORAL STEM LWJ STELKAST CO. SC1478 1332

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention