BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINECTIV TECHNOLOGY MODULAR NECK

    MDR report key: 1241106 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00835
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE KINECTIVE MODULAR NECK, STEM, AND ACETABULAR CUP WERE IN VIVO FOR 7 MONTHS UNTIL PATIENT PAIN AND CUP LOOSENING REQUIRED A REVISION OF THE CUP. THE KINECTIVE NECK HAD SOME STRIKE MARKS WHICH ARE A RESULT OF THE EXPLANTATION. SURGERY NOTES, PRE-OP AND POST-OP X-RAYS WERE NOT PROVIDED. IT IS UNKNOWN IF THE STEM HAD GOOD FIXATION. HOWEVER, WE KNOW THAT THE STEM WAS REVISED. THE STEM MAY HAVE CONTRIBUTED TO THE CUP LOOSENING BY IMPROPER LEG LENGTH, IMPROPER OFFSET, INCORRECT ORIENTATION, OR STEM LOOSENING. HOWEVER, THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. 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 IN 2008 AND EXPLANTED ON SEVEN MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINECTIV TECHNOLOGY MODULAR NECK HIP PROSTHESIS KWY ZIMMER, INC. NA 60880075

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R