BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 4101096 · Received September 19, 2014

    Report

    Report Number
    0001825034-2014-07812
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A LOOSE ACETABULAR CUP, METAL WEAR, AND TISSUE REACTION. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584107 UNKNOWN HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R