BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3980513 · Received August 5, 2014

    Report

    Report Number
    0001825034-2014-06828
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    May 26, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - 2000; PMA/510(K) NUMBER / MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN 2000. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO POLY WEAR. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BOTH LEFT AND RIGHT INITIAL HIP ARTHROPLASTIES APPROXIMATELY TWENTY YEARS AGO. SUBSEQUENTLY, A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO ACETABULAR LINER WEAR. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. PATIENT WAS REVISED ON THE RIGHT SIDE ON (B)(6) 2015 DUE TO INSTABILITY. THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457428 UNKNOWN HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R