BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT

    MDR report key: 1242223 · Received November 19, 2008

    Report

    Report Number
    1822565-2008-00806
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PATIENT WAS REVISED DUE TO THIGH PAIN, WHICH BEGUN APPROXIMATELY 9 MONTHS PRIOR TO REVISION. THE IMPLANT WAS IN VIVO FOR 1 YEAR. NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS HAVE BEEN PROVIDED WITH THIS COMPLAINT. THIGH PAIN CAN BE CAUSED BY MANY FACTORS INCLUDING (BUT NOT LIMITED TO) LOOSE FEMORAL AND/OR ACETABULAR IMPLANTS, FEMORAL FRACTURES, SURGICAL PROCEDURE, IMPROPER COMPONENT PLACEMENT OR SIZING, AND INFECTION. THE RETURNED IMPLANT SHOWS SIGNS OF OSTEOINTEGRATION ON ALL SIDES OF THE TRABECULAR METAL, WHICH LIKELY INDICATES ADEQUATE STEM FIXATION. THE EXACT CAUSE OF THE THIGH PAIN FOR THIS CASE CAN NOT BE DETERMINED WITH CERTAINTY AT THIS TIME. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED 2007 AND EXPLANTED 2008 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT HIP PROSTHESIS KWY ZIMMER, INC. NA 60629068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R