BEUDAMED
    FDA Adverse Event Other Summary report: N

    KWL OPTIMOM MODULAR HEADS

    MDR report key: 3660391 · Received January 29, 2014

    Report

    Report Number
    9614209-2014-00002
    Event Type
    Other
    Date Received
    January 29, 2014
    Date of Event
    September 7, 2011
    Report Date
    January 29, 2014
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    KWL
    PMA / PMN Number
    K111911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4). PT NOTES, MEDICAL HISTORY, DEVICE DETAILS, EXPLANT AND X-RAYS HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE HISTORY RECORDS TO BE REVIEWED. PLEASE NOTE: THIS EVENT IS REPORTED TO THE FDA DUE TO THE INCIDENT EXPERIENCED TO A DEVICE THAT IS SIMILAR TO A MEDICAL DEVICE THAT IS PLACED ON THE MARKET IN THE USA. HOWEVER, THIS WAS COUPLED WITH A THR WITH A LARGE DIAMETER MOM HEAD WHICH IS NOT CLEARED FOR SALE IN THE USA (INCIDENT WAS OUTSIDE OF USA).

    Description of Event or Problem · 1

    OPTIMOM REVISION DUE TO PAIN AND POSSIBLE ALVAL AFTER THREE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62711 KWL OPTIMOM MODULAR HEADS PROSTHESIS, HIP HEMI-, FEMORAL, METAL KWL CORIN MEDICAL, LTD. 179.252B MICB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ASSOCIATED OPTIMOM HEAD E079.744, LOT LXPN| ASSOCIATED METAFIX STEM 579.0001, LOT MCWL